Job Overview:
Optimi is a Canadian Good Manufacturing Practices (GMP) compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. The focus of the company is on pharmaceutical-grade psychedelics, including MDMA and naturally derived psilocybin products. From facilities in Princeton, British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and clinical trials in Israel, as well as accessible in Canada through the Special Access Program.
The QA Associate is part of the QA team responsible for administering and supporting GMP Quality Assurance programs to ensure compliance with regulatory requirements and adherence to quality standards at Optimi Labs. This role involves assisting in the implementation, maintenance, and improvement of GMP quality systems and processes to uphold product quality, safety, and regulatory compliance.
This is a full-time onsite role.
Responsibilities:
In conjunction with other members of the QA team, the following activities will potentially be performed:
Batch Record Review, Change Control, CAPA, OOS and Deviation Management:
- Thoroughly review batch records, ensuring accuracy and compliance with established procedures and regulatory requirements.
- Investigate and aid in addressing any discrepancies or deviations identified during batch record review.
- Evaluate and assess change control requests to determine the potential impact on pre-existing documentation and/or on product quality.
- Participate in investigation and resolution of CAPA, OOS and Deviation including the initiation, documentation, and tracking of these programs to align turnaround times with industry standards.
Document Management:
- Participate in the creation, revision, review and archiving of quality documentation, including standard operating procedures (SOPs), specifications, batch records, forms, protocols, and quality manuals.
- Ensure document revisions are accurately tracked, implemented, and communicated to relevant personnel in a timely manner.
- Ensure that all documentation is current, accurate, and in compliance with regulatory standards.
Training Program:
- Provide assistance in administering the training program for employees, including scheduling, tracking, and documenting training activities to ensure compliance with job-specific requirements and regulatory training mandates.
Quality Metrics and Reporting:
- Collect, analyze, and report quality metrics and key performance indicators (KPIs) to monitor the effectiveness of QA programs and identify opportunities for improvement.
- Prepare quality reports and presentations for management review meetings, regulatory submissions, and external audits.
Other GMP Responsibilities:
Environmental Monitoring:
- Monitor and assess environmental conditions within manufacturing and storage areas to ensure compliance with specified requirements.
- Investigate and address any deviations from established environmental monitoring standards.
- Coordinate entry of pest control third party vendor and documentation of results.
Vendor Management Program
- Support the approved vendor program via vendor qualification, performance monitoring, and periodic reassessment to ensure compliance with quality standards, regulatory requirements, and organizational objectives.
Water Sampling
- Routine water sampling for water systems and potable water at Optimi Labs
Quality Assurance & Regulatory Compliance:
- Assist in preparing documentation for regulatory filings and inspections.
Line Clearance & Sanitization:
- Approval for pre-operational line clearance
- Review and approval of sanitization program
Key Requirements:
- In progress to complete a university degree, diploma program or equivalent. All levels of experience will be considered.
- Previous experience in QA in a GMP or regulated environment is considered an asset, but full training will be provided.
- Knowledge of pharmaceutical quality systems, GMP, and regulatory requirements an asset.
- Strong attention to detail, analytical, and organizational skills.
- Effective communication and interpersonal skills.
- Ability to work collaboratively in a cross-functional environment.
- High Proficiency in MS Office.
- Legally eligible to work in Canada
Knowledge, Skills and Abilities:
- Science -- Use scientific rules and methods to solve problems.
- Active Learning -- Understand the implications of new information for both current and future problem solving and decision-making.
- Critical Thinking -- Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Judgment and Decision Making -- Consider the relative costs and benefits of potential actions to choose the most appropriate one.
- Writing -- Communicate effectively in writing as appropriate for the needs of the audience.
- Speaking -- Talk to others to convey information effectively.
- Active Listening -- Give full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
- English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- GMP background including laboratory notebook maintenance an asset.
Compensation
- Annual salary range of $55,000.00 to $60,000.00 based on a 40-hour work week
- 2 weeks annual vacation
- Participation in Company health benefit program
- Relocation Assistance
This is an on-site position and will require the successful candidate to permanently relocate to Princeton, BC (no remote work work available) Relocation Assistance and temporary housing support available.
While we appreciate all those who apply, only candidates selected for interview will be contacted.
Pay: $55,000.00-$60,000.00 per year
Benefits:
- Casual dress
- Disability insurance
- Extended health care
- Housing allowance
- Life insurance
- On-site parking
- Paid time off
- Relocation assistance
- Vision care
Work Location: In person
