Associate, Quality Assurance and Compliance

POSITION DESCRIPTION

Formative Pharma Inc. is seeking an Associate, Quality Assurance and Compliance to join our talented and growing team. Reporting to the Director, Quality Assurance and Compliance, the Associate, Quality Assurance and Compliance will perform a broad range of quality-related activities that support the Canadian GMP requirements and ensure the safety and quality of drug products released to the Canadian market. The position is responsible for completing tasks to ensure the compliance of systems, products, contract manufacturing organizations (CMO’s), and contract labs.

WHAT WE DO

Formative Pharma Inc. is a Canadian-owned medical device and pharmaceutical company focused on innovative patient care and improving patient outcomes. In alignment with our values of People First, Always; Quick, Nimble, and Adaptive; and Solutions Oriented we specialize in the development, registration and commercialization of specialty medical devices and pharmaceuticals. Our knowledgeable and passionate team is devoted to Leading the Way to Better Health by delivering healthcare solutions that enhance the quality of life for all Canadians!

WHAT YOU WILL DO

Quality Systems Support

• Initiate, review, process, and close internal and external change control records.
• Track, follow up, maintain, and complete change controls and their associated tasks.
• Initiate, investigate, close, and track deviations.
• Initiate, process, close, and track CAPAs and their associated tasks.
• Create, revise, review, and maintain Standard Operating Procedures (SOPs).
• Support maintenance of master document storage, archival, and retention.
• Support maintenance of the site training database and provide training to new employees.
• Other duties as assigned.

Compliance Support

• Support supplier quality oversight activities.
• Support review and maintenance of supplier quality documentation.
• Obtain, review, and maintain GMP evidence for foreign buildings.
• Assist with DEL and MDEL activities (annual licence renewals, addition of sites).
• Draft Annual Product Quality Review reports.
• Intake, track, and maintain inquiries, complaints, and reported problems.
• Support regulatory inspections and inspection readiness.
• Perform self-inspections and draft reports.
• Support evaluation of guidance document changes and compendial updates.

Product Release Support

• Support drug product release activities for the Canadian market.
• Review compliance of C of A’s, C of C/M’s, sterile executed batch manufacturing records, process validation protocols and reports, etc.).
• Support sample coordination to external labs for testing.
• Evaluate incoming inspection and temperature data of drug products.
• Initiate, track and investigate product-related deviations, CAPA, and change control records.
• Maintain the storage, archival, and retention of samples.
• Maintain compliance file records.

PREFERRED PROFILE

• Minimum bachelor’s degree in science (Chemistry or Life Sciences) or equivalent experience.
• Minimum of 2 years of practical experience in the pharmaceutical industry in QA.
• Proficient experience with change control in a regulated environment.
• Practical knowledge of a pharmaceutical quality systems environment (i.e., Deviations, CAPA, SOP’s, etc.).
• Experience with sterile drug products.
• Computer systems validation experience.
• Practical experience with Good Documentation Practices, investigational techniques, and executing Canadian GMP requirements.
• Independent, self-motivated individual with well-developed organizational and planning skills.
• Ability to work with shifting priorities and multiple projects.
• Excellent oral and written communication skills (in English).
• Strong computer skills i.e. MSOffice: Word, Excel, PowerPoint.
• Team-first mentality.

WHAT WE CAN OFFER YOU

• Competitive compensation package: our industry leading salaries are reviewed annually and we are proud to offer competitive benefits.
• Focus on work/life balance: we are committed to supporting our employees by offering flexible work hours, compressed work weeks, and investing in the health and wellness of our employees.
• ‘People first’ culture: we celebrate our team and their accomplishments through rewards and recognition initiatives, and host quarterly in-person gatherings and events.
• Values-driven company: we are unwavering in our ‘Patients First’ focus. Patients are at the center of what we do and why we do it.

Only those candidates selected for an interview will be contacted.

Pay: $80,000.00-$90,000.00 per year

Benefits:

• Casual dress
• Company events
• Dental care
• Employee assistance program
• Flexible schedule
• Paid time off
• Vision care
• Work from home

Work Location: Hybrid remote in Burlington, ON L7L 6A3