Pharmaceutical Quality Control Manager

Pharmaceutical Quality Control Manager Granulation Technology Inc Fairfield, NJ Job Details Full-time $100,000 - $130,000 a year 1 day ago Benefits Paid holidays Health insurance Dental insurance Paid time off Vision insurance Opportunities for advancement Retirement plan Qualifications Biology Dissolution testing USP standards Stability testing Laboratory equipment performance testing and validation Stability studies in drug product development Team leadership Pharmaceutical regulatory compliance High-performance liquid chromatographs Laboratory instrument validation Drug regulation Compliance audits & assessments Manufacturing facility Managing laboratory teams Analysis skills ICH guidelines Supervising experience Bachelor's degree Pharmaceutical analysis Ultraviolet-visible (UV-Vis) spectroscopy Quality control Quality compliance management Chemistry Verification of laboratory test methods Quality control within pharmaceutical industry Fourier-transform infrared (FTIR) spectroscopy Laboratory management Pharmaceutical product quality management Test validation method FDA regulations Full Job Description The Quality Control Manager is responsible for overseeing all QC laboratory activities, including raw material, in-process, finished product, stability, and cleaning validation testing. This individual will manage laboratory personnel, review analytical data, conduct investigations, and ensure data integrity and regulatory compliance. Essential Responsibilities Manage daily operations of the Quality Control laboratory. Develop, understand, and follow all QC laboratory related SOPs. Supervise and train QC analysts. Review and approve analytical data and laboratory documentation. Oversee testing of raw materials, packaging components, in-process samples, and finished products. Lead OOS, OOT, atypical result, and laboratory investigations. Ensure compliance with FDA cGMP, USP, and ICH guidelines. Maintain laboratory instruments and equipment qualification programs. Record and maintain QC Reference Standards and HPLC columns. Oversee stability programs and trend analytical data. Review and approve specifications, test methods, protocols, and reports. Support internal audits, customer audits, and FDA inspections. Collaborate with QA, Production, Regulatory Affairs, and R D teams. Ensure compliance with data integrity requirements (ALCOA+ principles). Qualifications Required Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or related scientific field. Minimum 5 years pharmaceutical QC experience. Minimum 2 years supervisory or management experience.

Strong knowledge of:

USP testing HPLC Dissolution UV/Vis FTIR Method validation Stability studies Experience with OOS/OOT investigations. Knowledge of FDA cGMP regulations. Preferred Experience in generic pharmaceutical manufacturing. Experience supporting FDA inspections. Experience with Empower or similar chromatography software. Experience with solid oral dosage products. Skills Strong analytical and problem-solving abilities. Excellent leadership and team development skills. Strong written and verbal communication. High attention to detail. Ability to manage multiple priorities in a fast-paced environment. Compensation & Benefits Competitive salary based on experience. Health, dental, and vision insurance. Paid time off and holidays. Retirement Plan. Career growth opportunities.

Pay:

$100,000.00 - $130,000.00 per year

Benefits:

Dental insurance Health insurance Retirement plan Vision insurance Application Question(s): How many years of pharmaceutical QC experience do you have? 0-2 3-5 5-10 10+ Have you managed QC analysts in a pharmaceutical laboratory? Yes No Have you conducted OOS investigations? Yes No Which analytical techniques have you used? (Select all) HPLC Dissolution

UV FTIR GC ICP

Other Have you worked in an FDA-regulated pharmaceutical manufacturing environment? Yes No Have you participated in an FDA inspection? Yes No Are you authorized to work in the United States?

Yes No Education:

Bachelor's (Required)

Experience:

Quality control: 5 years (Required) Laboratory management: 2 years (Required)

Work Location:

In person