Supervisor, Quality Control - Pharmaceuticals

MSN Pharmaceuticals Inc. (MSNPI) is one of the fastest-growing, research-based, generic pharmaceutical companies. We're looking for an experienced candidate who wants to grow with us at our state-of-the-art, team-based work environment in Piscataway, NJ!

Your Role and Responsibilities include but are not limited to:

• Supervise QC Operations in the testing of finished product and stability for controlled and non-controlled products.
• Provide technical troubleshooting as analytical issues arise during the laboratory testing. Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence.
• Supervises, trains and develops personnel to ensure good manufacturing practices (cGMPs) are followed and to enhance quality and quantity of work performed.
• Create work schedules, review and approval of laboratory documents (SOPs, Test Methods, Specifications, Certificate of Analysis, Reports).
• Review Certificate of Analysis, Stability Reports, Method transfer, Method verification and various other reports pertaining to Quality Control Laboratory.
• Responsible for ensuring all internal and contract laboratory testing GMP requirements are being met for product being commercially distributed and submission batches.
• Ensures that all policies (SOPs, Test Methods, Specifications, etc.) are maintained and adhered to within the laboratory.
• Ensures all laboratory deviations and investigations are properly investigated and writes/reviews investigations.
• Responsible for maintenance of working and reference standards, chemicals, columns ordering and inventory.
• Coordinates with contract testing laboratories to send the samples and get results for materials.
• Handling and inventory maintenance of DEA controlled drug substances/drug products and its related regulatory requirements.
• Responsible for method transfer activities related to raw materials and finished products.
• Responsible for coordinating with the vendors for preventive maintenance and calibration of all QC instruments and perform calibration of instruments in QC.
• Manage the disposition of the chemicals and samples in the laboratory.
• Manage employee relations, interviewing new hires and performance reviews.
• Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Additional duties may be assigned based on business needs.

Qualifications:

• Master's degree in Pharmaceutical Chemistry
• 10 years of experience in Analytical research and Quality Control departments
• Ability to lead laboratory staff to provide technical direction and training to include Good Manufacturing Practices, safety practices, and documentation practices as they relate to the quality assurance of the product
• Ability to independently lead appropriate root cause analysis and corrective action identification for raw material and vendor-related deviations/investigations
• Excellent written and verbal communication
• Strong leadership ability, including the ability to drive teamwork and employee engagement
• Good organizational and time management skills and have demonstrated ability to independently manage priorities, ensuring timely completion

Experience & Skills:

• 10 years of experience in the pharmaceutical industry and quality systems
• Experience in regulatory inspections like FDA, third party audits and DEA, etc.
• Strong written and verbal communication skills

Physical Demands/Factors:

• Work requires some exertion such as sitting for long periods of time, considerable walking, frequent bending, kneeling, reaching, and stooping. May include occasional lifting of moderately heavy objects.
• Specific vision abilities required includes close vision, distance vision, color vision and the ability to adjust focus.
• Noise: either constant or intermittent noise generated by Laboratory instruments.
• Ability to work safely around hazardous materials.

MSN Pharmaceuticals Inc. is an equal opportunity employer

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Work Location: In person