Quality Control Supervisor

Job Summary

Oversee physical/chemical/microbiological testing and analyses of pharmaceutical raw materials, excipients and finished drug products, including release, stability testing, cleaning verification test, and in-process testing. Supervise daily work of Chemists, Microbiologists and Technicians; provide guidance and directions when necessary. Conduct lab investigations and prepare deviations as needed.

Key Accountabilities

Testing

• Execute work schedule, review analysts’ notebooks and supervise analysts in day-to-day operations to ensure the compliance of SOP, cGMP, GLP, DEA regulations and/or MSDS.
• Understand analytical instrument operation/maint. of HPLC, UV-Vis, FT-IR, GC, dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Expert in analytical instrumentation to assure quality of test results.
• Review notebooks and instrument logbooks. Release test results to QA or other departments in a timely manner.
• Ensure timely completion of stability testing, provide data to regulatory groups, and conduct data trending during product shelf life.
• Perform methods development, transfer, verification and validation activities.
• Coordinate and assist with evaluation of Process Validations studies.

Documentation Practice, Training and Compliance

• Ensure work of staff is in compliance with good documentation practices per company's SOP and cGMP regulations in the laboratory.
• Prepare and review laboratory documents such as Laboratory Deviations, Investigations, and Test Methods in a timely manner.
• Enforce all applicable safety and standards guidelines, DEA regs and/or MSDS in lab. Ensure analysts are trained properly before they conduct corresponding testing.

Lab Maintenance

• Perform housekeeping on regular basis. Oversee general lab support; sample receiving, chemical inventory and document filing.
• Enforce safety by ensuring wearing of lab coat, safety shoes, safety glasses while in lab.
• Monitor ordering of lab supplies.
• Enforce the control and management of controlled substances.

Staff Development

• Evaluate potential candidates for QC; prepare annual performance evals. for chemists.
• Prepare chemists and laboratory for FDA and other compliance audits.
• Ensures adequate resources are trained to support compliance and business initiatives.

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• BS in chemistry, biochemistry, pharmacy, or related discipline. Advanced degree a plus.
• 7+ years of experience in pharmaceutical laboratory.
• 2+ year QC supervisory experience preferred.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc

• Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
• Proficiency required with laboratory techniques/instruments, such as pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.

Skills & Abilities

• Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
• Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
• Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; open to other ideas and tries new things.
• Planning/Organizing – Prioritizes/plans work; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules other people and tasks; develops realistic action plans.
• Safety and Security - Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.
• Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.
• Good verbal and written communications with basic computer skills.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc

• Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel. Work is performed in a FDA and DEA-regulated pharmaceutical lab environment with risk of exposure to various chemicals.
• Must occasionally lift and/or move up to 25 pounds. Lab coat and safety glasses required in work environment.
• Specific visions abilities are required by this job include close vision and color vision.
• The noise level in the work environment is usually moderate.
• The work environment is representative of a group laboratory environment.