QA Manager

6 months ago

Toronto, Canada Acorn Biolabs Full time

**Role**: QA Manager
- ______________________________________

With offices in Toronto and Los Angeles, Acorn is a next-generation personalized regenerative medicine company with services offered at partner clinics across Canada and the US. Acorn has developed the world’s first non-invasive, follicle-based cell cryopreservation service, launched in 2022, and has patented cell-based treatments made from a patient’s follicle cells in Aesthetics and Sports Medicine.

Acorn is also actively involved in scientific research with top healthcare and education institutions in North America, including the National Research Council, the University of Toronto, Mount Sinai Hospital, and the University of Calgary, to further the potential of cells in the follicle across many areas of general health.

Our values are important to us and set the culture of our company.

1. Integrity first- In our science, with our clients, with each other. Always.

2. Collaborate- Be kind, supportive, respectful, and inclusive. Be humble and grateful.

3. Show up- Take pride in your work. Be dependable, accountable, and disciplined. Strive for excellence - and be agile. Add value.

4. Be curious- Ask why. Constantly learn. Create. Innovate.

5. Have fun- Enjoy life Laugh - at yourself and with others. Be passionate about your work.

**Location: Toronto**

**What You’ll Do**
- Quality Management System (QMS):

- Ensure compliance with relevant industry regulations and maintain the Quality Management System.
- Guarantee adherence to regulatory and company data integrity standards.
- Management of GMP compliance issues with manufacturing sites, contract packagers, warehouse and contract laboratories, shipping and storage conditions.
- Develop and implement improved processes compliant to standards according to growing company needs
- Product Market Release:

- Lead and train others in market releases of batches of cosmetic products for the US and Canadian Market.
- Record Keeping:

- Maintain methods, Standard Operating Procedures (SOPs), training records, analyst books, audit reports, and Corrective and Preventive Actions (CAPAs).
- Manage the storage, retrieval, security, authorization, and distribution of working copies of documents.
- Maintain completed management reports.
- Certification
- Maintain site licenses compliant to INCI and MoCRA requirements
- Document Change Control:

- Write, revise, and approve SOPs and change control procedures.
- Verify the successful implementation of changes.
- Training:

- Conduct Good Manufacturing Practice (GMP) and ISO training.
- Cultivate a culture of quality company wide, adaptable to business needs
- Provide new employee training and ensure satisfactory completion.
- Audits:

- Manage both internal and external audits, including regulatory audits.
- Perform regular internal audits.
- Perform regular vendor audits.
- Prepare responses to auditor's reports.
- Out-of-Specification (OOS) Investigation:

- Evaluate investigation reports, approve corrective actions, and verify conformance.
- Issue, edit, and approve CAPAs.
- Data Review:

- Supervise the activity of all data reviewers.
- Review and approve all documentation generated in the laboratory, including calibration and external contractors.
- Calibration/Validation:

- Oversee calibration activities.
- Oversee the scheduling of equipment, tools, and instruments.
- Management Meetings:

- Provide departmental status updates.
- Maintain meeting minutes.
- Outline deviations, corrective, and preventive actions.

**What You’ll Need To Succeed**
- Bachelor's or Master's degree in Chemistry or a related discipline
- 5 to 7 years of related experience in Quality Assurance within pharmaceutical or cosmetic industries - additional certification or diploma in Regulatory Affairs is an asset.
- Expert knowledge of cosmetic/pharmaceutical manufacturing and laboratory processes. Experience with product life-cycle management is an asset.
- In depth knowledge of applicable Health Canada, FDA, and global cosmetic and pharmaceutical regulations (e.g. ICH, CFR)
- Experience auditing preferably with an auditing certification
- A self-starter who can take ownership of projects and issues, not hesitating to get hands-on when necessary.

**Additional Qualifications**:

- Excellent communication skills, both written and verbal.
- Articulate, organized, and detail-oriented.
- Able to work independently while collaborating within a team.
- Multitasking ability and composure under pressure.
- High level of professionalism, maturity, and discretion in dealing with confidential matters.
- Proactive, self-disciplined, and highly productive with a goal-oriented approach.

**Working Conditions**:
This position primarily involves office work, with desk-based computer tasks. Occasional lifting of up to 30 lbs. may be required. Handling of hazardous materials follows established safety procedures and requires appropriate Personal Protective Equipment (PPE).

**Why Acor

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