- Manage the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
- Coordinate and oversee QC analytical testing for GMP batch release and stability testing.
- Ensure QC equipment is maintained in a qualified GMP state.
- Prepare, review and execute tech transfer, qualification and validation protocols and reports as needed.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
- Coordinate and oversee all raw material testing (internal and external) in adherence to approved material specifications.
- Serve as QC lead during project team meetings. Participate in client calls and meetings
- Release raw materials from quarantine using SAP.
- Assist in developing and managing QC Chemistry budget.
- Review and approve data / reports during release & stability testing.
- Ensures laboratory compliance to established specifications and procedures.
- Report excursions/out of specifications results and conducts investigations as needed.
- Assure the implementation of appropriate and timely corrective actions.
- Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team.
- Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
- Interface with current and potential clients as well as interface with investigators during internal and external inspections.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Identify deviations and report possible preventative and corrective actions using Trackwise.
- Perform other duties as assigned.
Required Skills & Abilities:
- Sound understanding of analytical instrumentation and methodologies. For example, chromatography, electrophoresis, and spectrophotometry.
- Operate as a team leader, coordinate staff scheduling and training.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Develop staff to maximize contributions to team and company.
- Ability to multi-task and prioritize work assignments with little supervision.
- Excellent attention to detail.
- Computer proficiency required.
- Ability to accurately review and complete required documentation.
- Excellent written and oral communication skills.
- Excellent organization and analytical skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- Bachelor of Science degree with at least six (6) years’ industry experience in a GMP / GxP, or a comparable federally regulated environment, of which two (2) years are in a supervisory or managerial role.
- Chemistry or Biochemistry major.
- Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
- Experience in Systems, Applications and Products (SAP) software.
- Experience in Trackwise Deviation Management software.