Supervisor, Qc Analytical

About the role

We are PCI. Our investment is in People who make an impact, drive progress, and create a better tomorrow. The QC Analytical Supervisor supports all activities in the Quality Control Laboratory, including completing the majority of peer review in the department and approving most procedures used in the analytical department. Responsibilities include testing in-process samples, finished product samples, and raw materials, as well as communicating with clients regarding Out of Specification (OOS) and other Quality System Events.

The role requires knowledge of commonly-used analytic concepts, practices, and procedures within the field, along with familiarity with cGMPs as they relate to analytical test methodologies and practices.

Responsibilities

• Prioritize and distribute work to analysts in the QC Analytical laboratory.
• Conduct OOS and customer complaint investigations.
• Complete peer review of work executed within the analytical laboratory.
• Train new employees.
• Perform routine analytical testing of samples supporting incoming raw materials, in-process production, and finished product testing.
• Conduct analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer, and other instrumentation as required.
• Perform instrument calibrations and preventative maintenance as needed.
• Document laboratory work using laboratory worksheets/notebooks, ensuring detailed and CGMP-compliant records.
• Write, review, and revise SOPs as required.
• Supervise employees in the QC Analytical department.
• Interact with Quality Assurance, Operations, Research and Development staff, and clients on a regular basis.
• Other duties as assigned or required.

Special Demands

• Routine work requires walking, standing, bending, reaching, climbing stairs, and lifting or carrying objects typically weighing less than 50 lbs.
• Capacity to work on several tasks simultaneously and organize/prioritize work activities.
• Able to walk and drive between locations.
• Physically able to wear laboratory protective gowning and equipment, including gowns, goggles, face shields, respirators, and protective gloves.
• Comfortable working with and handling hazardous materials.

Work Environment

• Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities.
• Regular interaction with Operations staff, Research and Development staff, and clients.

Qualifications

• 5+ years of relevant Analytical Chemistry experience, preferably in Quality Control within a pharmaceutical manufacturing company.
• Experience working in a cGMP laboratory required.
• Experience working in a CMO (contract manufacturing/development organization) preferred.
• Prior leadership experience is preferred.
• Bachelor of Science in a scientific area of study.
• Master of Science in a scientific area of study and 3+ years of Analytical Chemistry experience, preferably in Quality Control, may substitute for the Bachelor’s degree requirement.
• Ability to prioritize tasks for staff and make informed decisions.
• Detail-oriented with strong oral and written communication skills.
• Excellent organization and interpersonal skills.
• Proficiency in Office Suite (Excel, Word, Access, and PowerPoint).
• Ability to multi-task in a dynamic environment with changing priorities.
• Resilient, able to quickly move forward despite challenges.
• Drive to achieve results for self and the team, capable of working with limited supervision.
• Positive attitude and strong team and cross-team collaboration skills.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Strong commitment to conducting business according to the highest legal and ethical standards, and continually pursuing excellence in manufacturing and delivery.