POSITION 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.

ESSENTIAL FUNCTIONS

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 

• 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 & Skills 

• 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.
• 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 communication with basic computer skills.

Physical Requirements 

• 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.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.