Mgr, Quality Control Stability

Job Description Summary
Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
The Manager, Quality Control Lab is responsible for overseeing day-to-day operations of the QC Lab group. Position will supervise and enforce cGMPs, GLPs, conducting investigations, methods transfer, verification of compendia methods, and training/coaching of new employees.
The Manager, Quality Control Lab is responsible for overseeing day-to-day operations of the QC Lab group. Position will supervise and enforce cGMPs, GLPs, conducting investigations, methods transfer, verification of compendia methods, and training/coaching of new employees.
QC Lab management mainly for a single site. Position may have up to 8 direct reports.

• Manage day-to-day operations of assigned section of QC laboratory.
• Schedule laboratory analyses for testing for commercial and R&D purposes. Release test results to QA or other departments in a timely manner.
• Understand analytical instrument operation and maintenance. Troubleshoot instrument problems for chemists and supervisors.
• Review chemist notebooks and instrument logbooks on regular basis. Review/approve validation protocol, report, and SQARs for raw material testing in a timely manner.
• Review/comment on articles affecting QC in USP Supplements and Pharmacopeial Forums.
• Coordinate/assist R&D lab in method transfer, verification and validation activities.
• Oversee the control and management of controlled substances.

Documentation Practice, Training & Compliance

• Monitor implementation of good documentation practice per company's SOP and cGMP regulation in the laboratory.
• Prepare, review or approve laboratory documents such as Laboratory Deviation, Test Method, Deviation Report and SOP in a timely manner.
• Monitor implementation of all applicable safety and standards guidelines, DEA regulations and /or MSDS in the laboratory.
• Provide chemists and supervisors with training in SOPs, analytical instrument, cGMP and other regulations. Develop, monitor and improve training system.
• Prepare chemists, supervisor and laboratory for FDA and other compliance audits.
• Periodically review USP, EP and JP monographs; update internal testing procedures accordingly.
• Represent QC lab to attend inter-departmental meetings.

Lab Maintenance

• Develop/monitor/improve: 1) lab instrument maint./calibration system; 2) sample, standard and chemical inventory and receiving system; 3) lab document filing system.
• Enforce wearing of laboratory coat and safety glasses while working in lab.
• Oversee ordering of lab supplies.
• Ensure lab area is clean; monitor expiration dates of all reagents and solutions.
• Monitor the overall laboratory productivity and efficiency.

Staff Development

• Evaluate potential candidates for QC and prepare annual performance evaluations to supervisors and chemists.

Qualifications
Education & Experience

• BS in chemistry, biochemistry, pharmacy or related discipline. Advanced degree a plus.
• 10+ years' experience in pharmaceutical lab, particularly in appropriate area of specialty.
• 3+ years of supervisory experience.

Knowledge

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

Skills & Abilities

• Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
• Customer Service - Manages difficult, emotional customer situations; responds promptly; solicits feedback to improve service; responds to requests for service and assistance; meets commitments.
• Quality Mgt - Looks for ways to improve/promote quality; demonstrates accuracy/thoroughness.
• Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Safety and Security - Observes safety/security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment/materials properly.
• Excellent written and oral communication skills.
• Treats people with respect and fairness.
• Good management and leadership skills with strong interpersonal and influencing skills.
• Flexibility in carrying out various assignments.

Physical Requirements
Physical & mental 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 in a FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.
• Must occasionally lift and/or move up to 25 lbs. Lab coat and safety glasses required.
• 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.

Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement:
At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
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.