Industry Career Opportunities

Alphora

Position Title: Senior Document Reviewers

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced Senior Document Reviewers to join our team.

Responsibilities:

Essential Job Requirements:

  • Perform timely data review (including drug substances, excipients, in-process materials, drug products, stability, analytical method validation documentation, microbiological testing etc.) to ensure accuracy, completeness and compliance with GLP, GMP, all applicable SOPs and regulatory requirements.
  • Perform internal audits ensuring the lab operations are carried out according to approved procedures and in accordance with GMP/cGMP requirements.
  • Review laboratory notebooks for incoming samples, standards, reagents, equipment etc.
  • Issue and reconcile controlled laboratory notebooks and other GMP documentation.
  • Archive and retrieve laboratory data and reports.
  • Periodic review of training records, SOPs, change control implementation, deviation and OOS investigations.
  • Prepare for and participate in client audits and regulatory inspections as required.
  • Oversee data review, documentation, C of A preparation activities as required.
  • Perform other tasks as required.

Education and Experience:

  • University degree in Science – preferably in Chemistry with experience in the review of data from chemistry and microbiology laboratories.
  • A minimum of 3 years Quality Assurance Document Reviewing experience in a regulated environment
  • Strong understanding of quality systems, Canadian, US, EU GMP requirements.
  • Knowledge of Compendia, analytical techniques and method validation.
  • Excellent verbal and written communication skills; and interpersonal skills.
  • Extremely results driven and organized.

IThe above positions are only applicable to permanent residence and/or Canadian citizens with a minimum degree in science.

To apply, please reference “Senior Document Reviewers” in the subject line and submit resume, cover letter and salary expectations to careers@avantirx.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Alphora

Position Title: Senior Laboratory Analyst

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced Senior Laboratory Analysts to join our team.

Job Requirements:

  • Efficient and timely analytical testing of routine as well as R&D samples (raw material, in-process and finished product) using instrumentation (80-90%) and wet chemistry (10-20%) techniques.
  • Demonstrated experience with method optimization and method validation.
  • Expert knowledge of HPLC and GC operation, associated software and sample preparation techniques.
  • Excellent instrumentation and analytical problem solving / troubleshooting skills.
  • Strong understanding of relevant GMPs, GLPs, SOPs, Health and Safety regulations and other established regulatory requirements.
  • Efficient planning and execution of assigned work with minimal supervision needed.
  • Flexibility to plan and prioritize multiple projects in parallel.
  • Ability to recognize instrumental and /or analytical issues as soon as they occur and suggest resolutions to Management.
  • Participation in Laboratory non-conformance investigations along with the QC Team Lead.
  • Reporting data in accordance with relevant regulations (GMP) and company SOPs.
  • Preparation of technical reports, SOPs and protocols, as assigned.
  • Demonstrated ability to provide technical and scientific support to other (junior) analysts.
  • Performing all work in accordance with all established regulatory, compliance and safety requirements.
  • Training junior analysts as required.
  • Maintaining professional relationship with Internal/External Customers.

Education, Experience, Knowledge, and Skills Requirements:

  • University (BSc) degree in chemistry or related field; advanced degree (MSc, PhD) is preferred.
  • Minimum 5 years of GMP laboratory experience, using GC and HPLC instrumentation.
  • Thorough understanding of HPFBI and FDA GMP requirements as relates to the job.
  • Understanding and efficient use of compendial methods and general chapters (USP, EP, etc).
  • Excellent decision making and problem solving capability.
  • Strong verbal and written communication skills for effective interpersonal interactions.
  • Must contribute to and foster the development of a healthy cooperative environment.
  • Must be flexible and capable of carrying multiple projects simultaneously.

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum three years of direct Canadian experience. Considering the nature of business a Clean Police Criminal Record is a pre-requisite of employment.

To apply, please reference “Senior Laboratory Analyst” in the subject line and submit resume, cover letter and salary expectations to careers@avantirx.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.

Alphora

Position Title: Organic Research Chemist

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for a highly motivated, experienced Organic Research Chemist to join our team.

Job Requirements:

  • Understanding and working knowledge of cGMP principles, company’s standard operating procedures (SOPs), and regulatory requirements.
  • Demonstrated sound knowledge of organic extraction processes and isolation techniques.
  • Ability to perform routine synthesis and develop effective extraction processes using multiple pieces of equipment.
  • Excellent theoretical and working knowledge of distillation.
  • Excellent working knowledge of analytical techniques supporting synthesis, extraction and distillation, like TLC, Column Chromatography, IR, GC, GC/MS, NMR, etc.
  • Managing hazardous waste as defined by the Illinois Environmental Protection Agency.
  • Supporting large scale production (50 - 100 gallon reactors), loading reactors, drum handling, large scale solids handling, filtration and centrifugation.
  • Ability to follow written instructions (SOPs, test methods, batch documents, etc.) and document results as per applicable requirements.
  • Set-up and use of medium scale (22, 50 and 100 liters) glass apparatus, large scale rotary evaporation.
  • Performing water and solvent washing of chromatography resins/gels.
  • Designing and evaluating synthetic routes for new compounds.
  • Providing R&D support, process improvement, scale-up, cost reductions and safety improvements.
  • Achieving production goals relative to Safety, Quality, Delivery and Cost.
  • Competently planning, executing and documenting synthetic complex extraction processes.
  • Reporting conclusions from data/results and communicating to management.
  • Identifying instrument/method problems related to synthesis, and ability to troubleshoot with minimal guidance.
  • Addressing unexpected outcomes/issues, proposing solutions, and resolve problems.
  • Demonstrated technical writing skills for preparing experimental plans, research reports and operating procedures.
  • Occasional assistance in other departments such as the formulations lab and packaging may also be required.
  • Other duties include cleaning, assembling and disassembling equipment, involvement in process development, occasional assistance in other departments such as the formulations lab and packaging.
  • Other tasks as assigned by the ARA senior management.

Education, Experience, Knowledge, and Skills Requirements:

  • M.Sc. degree in Chemistry, with minimum 3 years direct Canadian industrial and professional experience in organic synthesis and purification.
  • A thorough understanding of organic synthetic chemistry at the professional level
  • Advanced experience with general laboratory techniques such as distillation, filtration, column chromatography, TLC, closed transfer, reaction chemistry and crystallization
  • Experience with rotary evaporators, vacuum pumps/ovens and small/large scale glassware
  • Ability to work with moisture sensitive, controlled, and carcinogenic materials
  • Ability to safely handle flammable solvents
  • Mechanical aptitude
  • Must demonstrate sound communication, writing skills, and interpersonal skills
  • Detail oriented
  • Excellent decision making and problem solving capability
  • Strong verbal and written communication skills for effective interpersonal interactions
  • Must contribute to and foster the development of a healthy cooperative environment
  • Must be flexible and capable of carrying multiple projects simultaneously

The above positions are only applicable to permanent residence and/or Canadian citizens with a minimum three years of direct Canadian experience. Considering the nature of business a Clean Police Criminal Record is a pre-requisite of employment.

If you meet the above requirements, we would like to hear how you could contribute to our team!

To apply, please reference “Organic Research Chemist” in the subject line and submit resume, cover letter and salary expectations to careers@avantirx.com

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.


Position Title: IT Specialists

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced IT Specialists to join our team.

Key Responsibilities:

  • Assist with the administration, maintenance, optimization, operating system patch management and technical support of the production and development environments.
  • Must ensure availability, reliability and scalability of all servers/storage which includes all application, file and print.
  • Evaluate and recommend server-based solutions to meet changing business requirements to allow staff to work and support the business remotely.
  • Coordinate and ensure compliance with Windows Server disaster recovery and contingency plans to assure the rapid recovery of systems in the event of an emergency of disaster.
  • Assist in ensuring backups are completed correctly for the Windows environments.
  • Assist with testing the Windows backup/restore process on a minimum bi-annual basis.
  • Install, administer, maintain and support various server applications.
  • As needed provide support for all desktop hardware and software.
  • Handle other duties as assigned by Management.

Requirements:

Our ideal candidate will have the following qualifications:

  • Strong problem-solver and team player who is confident and challenged in a fast-paced environment.
  • Detailed-oriented and be able to effectively prioritize his/her efforts, follow-up to ensure all aspects of the engagement are addressed, and escalate issues appropriately.
  • Proactive and results-oriented with good time management skills and the ability to work well under pressure and focus on multiple projects concurrently.
  • Ability to work independently as well as within a team.
  • Excellent organization and interpersonal skills.
  • Excellent verbal and written communications, including presentation skills.
  • Occasional travel may be required.

The above positions are only applicable to permanent residence and/or Canadian citizens with direct experience in pharmaceutical computer system validation.

If you meet the above requirements, we would like to hear how you could contribute to our team!

To apply, please send an e-mail to careers@avantirx.com referencing “IT Specialist” in subject line together with your resume and a covering letter.

We thank all applicants for their interest, however, only those selected for an interview will be contacted. No phone calls please.


Position Title: Production Technician

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced technician to join our team.

Job Duties:

  • Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies.
  • Prepares equipment by performing cleaning-in-place,); conducting operator inspections; performing preventive maintenance checks.
  • Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
  • Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
  • Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
  • Documents production by completing forms, reports, logs, and records of equipment and batches.
  • Updates job knowledge by participating in training opportunities.

Pharmaceutical Manufacturing Technician Skills and Qualifications:

Equipment Calibration, GCP, Manufacturing Methods and Procedures, Manufacturing Quality, Production Planning, Attention to Detail, Thoroughness, Documentation Skills, Analyzing Information.

The above position is only applicable to the Canadian permanent residence citizens with a minimum degree in science and 3 years of direct Canadian pharmaceutical experience in Quality Control and Manufacturing.

We offer competitive salary, medical insurance plan, and exceptional career development.

If you meet the above requirements, we would like to hear how you could contribute to our team!

To apply, please send an e-mail to careers@avantirx.com referencing “Production Technician” in subject line together with your resume and a covering letter.

We thank all applicants for your interest, however, only those selected for an interview will be contacted.


Position Title: Metrology

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced Metrology to join our team.

Overall Responsibilities:

The candidate will perform qualification and maintenance activities of lab instruments and equipment.

Specific Tasks:

  • Participate in new instrument requirement determination activities.
  • Develop instrument qualification documents including but not limited to:
  • IQ, OQ and PQ Protocols
  • IQ, OQ and PQ Summary Reports
  • Execute qualification protocols.
  • Write and review related technical documents.
  • Maintain calibration and preventative maintenance schedule.
  • Develop and formalize calibration procedures ensuring all laboratory instruments have calibration SOPs.
  • Perform calibration testing in accordance with these procedures.
  • Perform preventative maintenance on analytical instruments.
  • Monitor maintenance status of individual instruments and coordinate with external service technicians as required.
  • Maintain calibration data in an organized format.
  • Perform all work in compliance with GXP, company SOPs and regulatory and safety standards.
  • Perform other related duties as assigned.

Expectations:

We are looking for an independent and self-sufficient person willing to learn. Critical thinking a must. Specialized and specific training will be provided. Ours is a fast-paced environment with multiple responsibilities offering unparalleled exposure to analytical instrumentation in use in pharmaceutical environments.

The above position is only applicable to permanent residence and/or Canadian citizens with a minimum degree in science and minimum of 2 years of pharmaceutical lab experience with emphasis on instrumental methods.

We offer competitive salary, medical insurance plan, and exceptional career development.

If you meet the above requirements, we would like to hear how you could contribute to our team!

To apply, please send an e-mail to careers@avantirx.com referencing “Metrology” in subject line together with your resume and a covering letter.

We thank all applicants for your interest, however, only those selected for an interview will be contacted.


Position Title: Quality Assurance Specialists

ARA – Avanti Rx Analytics Inc. is Canadian Controlled Substances Contract Organization offering analytical, extraction, formulation, packaging services to its national and international clients.

We have a great team of highly educated, experienced, passionate, and committed personnel.

We offer a highly competitive salary, medical insurance plan, and exceptional career development, and “the satisfaction that comes from knowing that the services we provide and the products we produce will improve the quality of human lives”.

We are currently looking for highly motivated, experienced Quality Assurance Specialist to join our team.

Outstanding opportunity for Quality Assurance professionals to join our company based in Brampton as Senior Quality Assurance Specialists. As the Quality Assurance Specialist you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice), and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews and analysis.

Responsibilities:

  • Manage the GMP Documentation, Change Control, CAPS, OOT, OOS, Training Record systems.
  • Review and approve CoA and other quality documentation
  • Review validation activities
  • Assess regulations
  • Develop quality policy
  • Perform timely data review with a high focus on data quality to ensure accuracy and completeness of analytical testing documentation.
  • Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
  • Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
  • Review internal logbooks for incoming samples, standards, reagents, equipment etc.
  • Issue and reconcile Quality Control laboratory workbooks and other GMP documentation.
  • Audit and inspect laboratory equipment daily use logbooks
  • Ensure analysis performed are as per client’s specification
  • Track tests in progress and issue periodic status reports
  • Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
  • Implement Quality Policies and Procedures for on-site test activities
  • Develop, implement and update QA Manual, QA Supplement Manual and standard operating procedures
  • Prepare, review and approve Standard Operating Procedures (SOPs)
  • Archive and retrieve quality control data
  • Audit and inspect laboratory operation and activities
  • Audit and review data for accuracy, completeness and regulatory compliance
  • Detailed audits of draft reports for compliance with SOP’s and GLP regulations
  • Participate in client audits and inspections
  • Participate in regulatory audits and inspections
  • Oversee the laboratory investigation
  • Perform Annual Internal Audit, and work with Analytical Lab personal to ensure follows up and corrective actions are completed.
  • Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
  • Maintaining and issuing controlled numbers in support of site-wide document control
  • Tracking document requests and ensure completion of outstanding items
  • Conduct QA investigation with regard to Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
  • Assist in the review and approval of GMP documents such as SOPs, and associated forms, and initiate revisions.
  • Evaluate laboratory results and keep trending of ARA Stability studies and write assessment reports of these programs annually.
  • Any other tasks assigned by the ARA senior management

Education and Experience:

  • University Degree in Science – preferably in Chemistry coupled with experience in the review of raw material, finished product, stability and analytical method validation documentation.
  • Have experience in a Quality Assurance leadership role with minimum of 3 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
  • Have expert experience of GMP Thorough understanding of pharmaceutical QA Systems, US, EU, and Canadian GMP regulations
  • Knowledge of GMP, GLP, Compendia, analytical techniques
  • You should have excellent verbal and written communication skills, interpersonal skills and you should be extremely results driven and organized
  • You must demonstrate good written and oral communication skills in English

General Skills:

  • The requirements listed below are representative of the knowledge, skill, and/or ability required.
  • Must be willing to work in a team-based environment
  • Must have solid math skills
  • Must be able to work with limited direct supervision
  • Must have good problem solving/organizational skills
  • Must have excellent computer skills
  • Must have strong writing and communication skills in English
  • Must have the ability to analyze data
  • Must be attentive to detail
  • Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required

The above positions are only applicable to permanent residence and/or Canadian citizens with a 3 years minimum degree in science.

We offer competitive salary, medical insurance plan, and exceptional career development.

If you meet the above requirements, we would like to hear how you could contribute to our team!

To apply, please send an e-mail to careers@avantirx.com referencing “Senior QA Specialist” in subject line together with your resume and a covering letter.

We thank all applicants for your interest, however, only those selected for an interview will be contacted.