What are the responsibilities and job description for the Quality Control (QC) Manager position at MediNatura Inc.?
Position Summary:
The Quality Control Manager is responsible for the overall daily performance and operation of the QC Department to ensure high quality analytical support for manufacturing while complying with internal procedures, cGMP for pharmaceuticals, and safety requirements. The QC Manager will supervise direct reports to ensure accurate, timely and compliant testing and reporting. The Quality Control Manager is responsible for ensuring overall GMP compliance in the QC Department and ensuring products are made to specifications. They will work closely in cross functional teams and ensure the department is wholly and fairly represented.
Primary Position Responsibilities:
- Overall management of daily activities of QC Function
- Provide leadership, management, and evaluation to QC Staff.
- Perform payroll requirements for lab employees.
- Develop QC Lab budget for operating and equipment expenses using a strategic approach.
- Monitor QC expenditures to ensure they fall within budget allowances.
- Research the feasibility of developing in-house testing procedures vs. outsourcing.
- Research and implement new QC Lab equipment and procedures as budget allows.
- Take a leading role in the validation of QC Lab equipment and methods as required.
- Take a lead role in the QC Lab portion of other validations throughout the facility.
- Take a lead role in the QC Lab portion of new product development efforts.
- Research contract lab services to be used by MediNatura and ensure they are qualified.
- Serve as subject matter expert for QC Laboratory operation.
- Ensure the timely, accurate, and compliant inspection/testing of drug product components and raw materials, in-process, and finished goods.
- Develop and maintain vendor certification schedules for affected components.
- Develop, review, and maintain QC Lab SOP’s and conduct training for all affected employees.
- Review QC Lab documentation for completion, accuracy, and compliance
- Maintain QC Lab files / documentation so they are readily retrievable.
- Monitor QC Lab supply inventory to prevent testing backlog, including research of new supplies.
- Take lead in QC Lab investigations and reporting due to drug product complaints, discrepancy reports, OOS’s, OOT’s, etc.
- Oversee QC tech activities to ensure they are carried out in a timely and accurate manner:
- Stability Testing
- Calibration Schedule
- Returns processing
- Employee Product Center
- Reserve Sample maintenance
- Perform training / coaching / employee development / disciplinary action for direct reports to ensure reliable and accurate employee performance.
- Ensure compliance with FDA and OSHA requirements as related to QC Lab functions.
- Must comply with the current Good Practices (cGMP’s) for drug products as defined in the Code of Federal Regulation, Title 21 Parts 210 and 211, SOP's and company policies in all work.
- Reinforce department and company policies to promote and support a positive work environment.
- Ensure timely reporting and releases of materials, products, and reports to other departments.
- Effective and efficient communication of any GMP issues that would hamper business goals and provide timelines for investigation completion.
- Oversee and be responsible for reporting cost of quality metrics with the assistance of Production and Sales information.
Other Responsibilities:
- Perform payroll duties for direct reports.
- Schedule QC personnel so that it is QC daily required functions are covered as necessary.
- Perform performance reviews for direct reports.
- Perform any other duties assigned by management.
Essential Skills and Experience:
- Bachelor’s degree in chemistry and/or biology; Maybe waived with certain experience.
- At least 5 years’ experience working in a pharmaceutical lab environment or a similarly regulated industry, preferably in a Directorial or supervisory role.
- Able to work with lab equipment such as analytical balance, glassware, calculator, thermometer.
- Excellent investigation and problem-solving skills
- Able to read, write, understand, and follow technical instructions and procedures.
- Knowledge of current Good Manufacturing Practices for drugs or medical devices
- Excellent organizational, verbal, and written communication skills
- Understand regulations, working in a regulatory environment.
- Able to lead and motivate individuals and teams with a positive attitude.
- Able to interact with all levels of employees in a professional manner.
- Proactive approach to problem solving.
- Able to maintain confidentiality and resolve employee relation issues.
- Prior experience supervising
- Proficient in Microsoft Word, Excel, PowerPoint, and Outlook
- Must be able to lift and carry 25 lbs. from the floor.
Valued but not required skills and experience:
- Knowledge of basic Quality Assurance Principals
- Experience working with external testing laboratories and CMO development and manufacturing partners.
Reporting To This Position:
Quality Control Supervisor
Quality Control Lab Assistant
Quality Control Lab Technician
General Sign-Off:
The employee is expected to adhere to all company policies and to act as a role model in the adherence to policies.