Quality Control Chemistry Supervisor

• Perform and oversee testing of raw materials, in-process samples, stability samples, and finished pharmaceutical products.
• Execute and review analyses using HPLC, UPLC, GC, FTIR, UV-Vis, dissolution, LC-MS, GC-MS, and other analytical techniques.
• Troubleshoot laboratory instrumentation and analytical methods.
• Ensure testing is completed in accordance with approved methods, specifications, SOPs, and regulatory requirements.
• Review laboratory data for accuracy, completeness, and compliance.

Technical Leadership

• Serve as a subject matter expert for analytical testing and laboratory investigations.
• Lead Out-of-Specification (OOS), Out-of-Trend (OOT), deviation, and laboratory investigation activities.
• Support analytical method validation, verification, transfer, and robustness studies.
• Assist with implementation of new technologies, instrumentation, and laboratory processes.
• Provide technical recommendations to Quality, Manufacturing, Regulatory Affairs, and R&D teams.

Supervisory & Team Lead Responsibilities

• Provide daily direction and workflow coordination for QC Chemists and laboratory analysts.
• Train, mentor, and onboard new laboratory personnel.
• Review laboratory notebooks, worksheets, and analytical documentation.
• Assist management with scheduling, workload balancing, and laboratory resource planning.
• Participate in employee performance evaluations and development planning.
• Serve as acting laboratory lead in the absence of the QC Manager or Supervisor.

Compliance & Quality Systems

• Ensure compliance with cGMP, GLP, data integrity, and company quality standards.
• Support CAPA implementation and effectiveness verification activities.
• Participate in internal audits, customer audits, and regulatory inspections.
• Maintain laboratory equipment calibration, qualification, and preventive maintenance programs.
• Drive continuous improvement initiatives to improve laboratory efficiency and compliance.

Qualifications:
Education

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline required.
• Master's degree preferred.

Experience

• 5-8+ years of pharmaceutical quality control laboratory experience.
• Demonstrated experience in FDA-regulated cGMP environments.
• Prior experience mentoring, training, or leading laboratory personnel.
• Experience supporting commercial pharmaceutical manufacturing operations preferred.

Technical Skills

• Advanced proficiency with:
  • HPLC / UPLC
  • Gas Chromatography (GC)
  • FTIR
  • UV-Visible Spectroscopy
  • Dissolution Testing
  • LC-MS / GC-MS
  • Chromatography Data Systems (CDS)

• Strong understanding of:
  • FDA regulations
  • cGMP requirements
  • ICH guidelines
  • Data integrity principles
  • OOS/OOT investigations
  • CAPA systems
  • Method validation and transfer

Leadership Competencies

• Demonstrated ability to mentor and develop scientific staff.
• Strong problem-solving and decision-making skills.
• Excellent organizational and project management abilities.
• Effective communication and cross-functional collaboration skills.
• Ability to balance technical responsibilities with team leadership duties.

Preferred Qualifications

• Experience leading laboratory investigations and regulatory responses.
• Previous supervisory or team lead experience.
• Experience supporting FDA inspections.
• Knowledge of stability programs and analytical method lifecycle management.
• Experience in generic pharmaceutical manufacturing and/or sterile products.

Benefits

• Competitive salary
• Medical, dental, and vision insurance
• 401(k) plan
• Paid time off

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.