Quality Control Chemistry Manager
hace 5 días
Sacramento
Position Summary: A rapidly growing specialty pharmaceutical company is seeking a Quality Control Chemistry Manager to lead the day-to-day operations of the Quality Control Chemistry laboratory in support of pharmaceutical manufacturing, release testing, stability testing, method validation, and regulatory compliance. This role provides technical, operational, and people leadership to QC Chemists, Senior Chemists, Analysts, and laboratory support personnel. The QC Chemistry Manager ensures that all laboratory testing is completed accurately, efficiently, and in compliance with cGMP, FDA, ICH, USP, and company quality requirements. This position serves as a key laboratory leader, supporting investigations, audits, regulatory inspections, continuous improvement initiatives, and cross-functional collaboration with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, and R&D. Key Responsibilities Laboratory Leadership • Manage daily operations of the QC Chemistry laboratory, including testing priorities, staffing, scheduling, and workload allocation., • Supervise, coach, and develop QC Chemists, Senior QC Chemists, Analysts, and laboratory support staff., • Ensure timely completion of raw material, in-process, finished product, cleaning validation, and stability testing., • Monitor laboratory performance metrics, testing turnaround times, backlog, deviations, and resource needs., • Support hiring, onboarding, training, performance evaluations, and development planning for laboratory personnel. Analytical Testing & Technical Oversight • Provide technical oversight for analytical testing using HPLC, UPLC, GC, FTIR, UV-Vis, dissolution, Karl Fischer, wet chemistry, LC-MS, GC-MS, and other laboratory techniques., • Review and approve analytical data, laboratory records, notebooks, worksheets, and test results., • Ensure proper execution of approved methods, specifications, protocols, SOPs, and compendial requirements., • Support method development, method validation, method verification, method transfer, and lifecycle management activities., • Troubleshoot complex analytical methods, instruments, investigations, and laboratory issues. Compliance & Quality Systems • Ensure laboratory operations comply with cGMP, GLP, FDA regulations, ICH guidelines, USP requirements, and internal quality standards., • Lead or support OOS, OOT, deviation, laboratory error, and atypical result investigations., • Review and approve investigation reports, root cause analyses, CAPAs, and effectiveness checks., • Maintain laboratory readiness for FDA inspections, customer audits, and internal audits., • Ensure compliance with data integrity requirements, including ALCOA+ principles and proper use of chromatography data systems. Equipment, Systems & Documentation • Oversee laboratory equipment qualification, calibration, preventive maintenance, and troubleshooting., • Ensure appropriate use and administration of laboratory systems, including LIMS, CDS, ELN, and equipment software., • Author, review, and approve SOPs, protocols, reports, specifications, and laboratory procedures., • Maintain accurate and inspection-ready documentation for all laboratory activities., • Support implementation of new analytical technologies, instruments, and process improvements. Cross-Functional Support • Partner with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, Supply Chain, and R&D to support product release, investigations, technical transfers, and commercial operations., • Support regulatory filings, customer requests, and inspection responses as needed., • Provide chemistry subject matter expertise for change controls, CAPAs, deviations, validation activities, and process improvement projects., • Participate in cross-functional meetings related to production schedules, batch release, stability programs, and quality initiatives. Qualifications Education • Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline required., • Master's degree or advanced degree preferred. Experience • 8+ years of pharmaceutical quality control chemistry laboratory experience., • 3+ years of supervisory, team lead, or laboratory management experience., • Experience working in an FDA-regulated cGMP pharmaceutical manufacturing environment required., • Experience supporting regulatory inspections, customer audits, and quality system investigations preferred. Technical Skills • Strong technical knowledge of pharmaceutical analytical chemistry., • Hands-on experience or strong oversight experience with HPLC, UPLC, GC, FTIR, UV-Vis, dissolution, wet chemistry, and compendial testing., • Experience with OOS/OOT investigations, deviations, CAPA, change control, and laboratory quality systems., • Knowledge of FDA regulations, cGMP, ICH guidelines, USP/NF, and data integrity expectations., • Experience with chromatography data systems, LIMS, ELN, and electronic quality systems preferred., • Strong understanding of method validation, method transfer, equipment qualification, and stability testing. Leadership Competencies • Strong people leadership, coaching, and staff development skills., • Ability to manage competing priorities in a fast-paced manufacturing environment., • Strong technical decision-making and problem-solving abilities., • Excellent written and verbal communication skills., • Strong attention to detail, documentation quality, and regulatory compliance., • Ability to collaborate effectively across Quality, Manufacturing, R&D, Regulatory, and Validation teams. Preferred Qualifications • Prior experience managing a QC Chemistry laboratory in generic pharmaceutical, sterile product, oral solid dose, or CDMO manufacturing., • Experience preparing for or directly supporting FDA inspections., • Experience managing laboratory budgets, headcount planning, and capital equipment requests., • Experience improving laboratory turnaround times, reducing backlog, and strengthening compliance systems., • Experience with stability programs, cleaning validation testing, and analytical method lifecycle management. Benefits • Competitive salary, • Medical, dental, and vision insurance, • 401(k) plan, • Paid time off #IND-SPG Estimated Min Rate: $125000.00 Estimated Max Rate: $135000.00 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. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice
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