Position Summary
A rapidly growing specialty pharmaceutical company is seeking a Quality Control Chemistry Supervisor to serve as a technical leader within the Quality Control laboratory, responsible for performing advanced analytical testing, leading laboratory investigations, supporting method validation activities, and providing day-to-day guidance to junior chemists and laboratory staff. This role combines hands-on laboratory responsibilities with leadership duties to ensure timely and compliant testing of pharmaceutical materials and products.
The ideal candidate possesses extensive experience in pharmaceutical quality control, strong expertise with analytical instrumentation, and demonstrated ability to mentor team members while maintaining compliance with FDA, cGMP, and ICH requirements.
Key Responsibilities:
Analytical Testing & Laboratory Operations
- 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
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Estimated Min Rate: $110000.00
Estimated Max Rate: $125000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- 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.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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