Quality Compliance Systems Coordinator

4 weeks ago

SaintLaurent, Canada Actylis Canada (A&C American Chemicals Ltd.) Full time

**Who we are**:
A&C provides a number of services for the pharmaceutical and biopharmaceutical industries, aimed at solving customers technical, production, stability and regulatory issues. A&C is a speciality GMP manufacturer and custom packager of excipients, process solutions, buffers and APIs.

**What we offer**:

- Corporate bonus program
- Employer contribution to A&C’s health, dental, and life insurance plan
- Telemedicine program
- Social events
- Educational and developmental program
- Yearly health and physical wellness benefit

**Basic Function and Scope of Responsibilities**:
Responsible for all matters related to the documentation of the various systems, processes, and SOPs embedded within Actylis Montreal’s Quality Management system with regards to Quality Control. The Quality Control Systems Coordinator is also responsible for all the investigations, validation, and stability programs. He or she must communicate closely with the Quality Control Laboratory Supervisor. The incumbent must also contribute to the product development in compliance with cGMP practices, quality standards and regulatory requirements.

**Principal Tasks/Responsibilities**:

- Perform peer review of the testing results to ensure compliance with specifications, pharmacopeias, SOPs and cGMP requirements.
- Review and release test sheets and Certificate of Analysis for the products where a signature is required.
- Ensure maintenance of all records including laboratory notebooks within GDocP
- Conduct laboratory investigations and generate reports for out-of-specification (OOS), out of trends (OOT), deviations, non-conformances and/or customer complaints.
- Provide technical expertise and support in the design, implementation and management of stability programs including assessment of stability indicating methods, drafting of protocols, stability sample pull-out and testing schedule, data summary/trending and authoring of reports.
- Contribute to analytical method development, qualification/validation and transfer.
- Author SOPs, analytical procedures, validation protocols and reports.
- Lead method development, assay validation and characterization for raw materials and products.
- Lead the introduction and validation of new laboratory equipment and generate protocols and reports, as required.
- Assist with troubleshooting quality control issues.
- Identify opportunities for continuous Improvement to further optimize our laboratory function.
- Maintain data integrity and ensure compliance with Quality Management System requirements, cGMP standards and regulatory requirements.
- Work closely with other members of Quality Assurance, Technical Operations, R&D and Customer Service departments to support new product introduction projects and ensure delivery of key project objectives.
- Follow SOPs for tracking and documentation responsabilities specifically related to the quality control department.
- Ensure company quality management system is being followed by the Quality Control Unit.
- Assist with internal and external GMP auditing when required.
- Revise or produce new SOPs, programs, specifications and protocols necessary for laboratory operations.

**Ancillary tasks/Responsibilities**:

- Perform supportive activities for general lab readiness and laboratory instrument set-up and maintenance.
- Ensure maintenance of health and safety standards;
- Attend appropriate Good Manufacturing Practices (GMP) training courses.
- May be called upon to act as back up for Quality Control Laboratory Supervisor, as required.
- Support in Quality Control testing of raw material, intermediates, finished products and stability samples, as required.

**Educational Requirements**:

- Indicate the minimum level of formal education that is required to perform this job satisfactorily._
- A bachelor degree in chemistry, biochemistry or a related discipline.
- Member is in good standing with the Order of Chemists of Quebec (OCQ).

**Experience Qualifications - Required(R)/Preferred(P)**:
Required (R):

- Demonstrate accuracy and proficiency in analytical skills in a cGMP laboratory.
- Strong problem-solving skills.
- Attention to details.
- **Member of the Order of Chemists**:

- Sense of organization and priorities.
- Strong oral and written communication skills.
- Two (2) years of experience in GMP environment.
- Analytical experience in GC, UV-Vis, FTIR and compendial testing techniques.
- Team Player.

Language Experience:

- Bilingual (English and French) (R)

**Job Types**: Full-time, Permanent

**Salary**: $60,000.00-$65,000.00 per year

**Benefits**:

- Commuter benefits
- Dental care
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision care

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Supplemental pay types:

- Bonus pay

Ability to commute/relocate:

- Saint-Laurent, QC: reliably commute or plan to relocate before starting work (req

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