Job Overview
We are seeking a dynamic and detail-oriented Quality Control Senior Scientist to lead our quality assurance initiatives within a fast-paced manufacturing environment. The position leads analytical testing, method development, and investigation activities for raw materials, in-process samples, and finished products across medical devices and pharmaceutical manufacturing. This role serves as a technical resource and mentor within the QC laboratory, driving compliance with regulatory standards (FDA, ISO 13485, cGMP) and internal quality specifications, while leading complex investigations and continuous improvement initiatives.
Responsibilities
- Lead and perform advanced chemical, physical, and microbiological testing per approved methods (Wet Chemistry, HPLC, FTIR, TOC, pH, conductivity, endotoxin, and bioburden)
- Develop, qualify, and validate new and existing analytical test methods; author method validation/verification protocols and reports
- Record all test data contemporaneously in laboratory notebooks, worksheets, or electronic data systems in accordance with ALCOA+ data integrity principles
- Review and approve analytical data generated by QC Scientists for accuracy, completeness, and compliance prior to release
- Lead OOS/OOT investigations and root cause analyses; author and drive CAPA activities to closure
- Serve as a subject matter expert during internal and external audits (FDA, ISO, customer), including hosting and presenting to auditors
- Author, review, and approve SOPs, test methods, method validations, and other QC documentation
- Mentor and provide technical training to QC Scientists and laboratory staff
- Oversee instrument qualification, calibration, and troubleshooting programs
- Ensure compliance with cGMP, GLP, FDA 21 CFR Parts 210/211/820, and ISO 13485
- Partner with Manufacturing, R&D, Regulatory, and Quality Assurance leadership to resolve complex quality issues and support product lifecycle initiatives
- Contribute to risk assessments and continuous improvement projects within the QC laboratory
Requirements
- Bachelor's degree in Chemistry, Biology, Microbiology, or related science required; Master's degree preferred
- 5+ years of QC laboratory experience in medical device, pharmaceutical, or related industry setting, including demonstrated method development/validation experience
- Advanced proficiency in pH, conductivity, and TOC analysis
- Strong competency in wet chemistry techniques including titrations
- Demonstrated experience with HPLC, FTIR, and data acquisition software (e.g. Empower)
- Working knowledge of FDA regulations, ISO 13485, and cGMP requirements
- Proven track record leading investigations, method validations, and audit support
- Strong documentation, investigation, and problem-solving skills
- ASQ CQE or CQA certification preferred
Competencies & Attributes
- Strong attention to detail and commitment to data accuracy and integrity
- Demonstrated leadership and mentoring ability within a laboratory setting
- Excellent organizational skills with the ability to manage multiple concurrent projects and priorities
- Clear and professional written and verbal communication skills, including audit and cross-functional presentation experience
- Ability to work independently, exercise sound scientific judgment, and lead cross-functional collaboration
- Proactive, quality-first mindset with strong critical thinking and root-cause problem-solving skills
Join us to be part of a passionate team dedicated to excellence in manufacturing quality! We offer an engaging environment where your expertise will directly impact product safety and customer satisfaction while supporting your professional growth in a thriving industry.
#PKJOBS
Pay: $90,000.00 - $105,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Retirement plan
- Vision insurance
Work Location: In person
