Sr. Quality Control Analyst; Pharma
Listed on 2026-07-21
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Research/Development
Regulatory Compliance Specialist, Biotech Research
Shift: Monday through Friday, 8:00AM – 5:00PM
OverviewJoin our mission to continuously move science forward and improve the health and safety of communities worldwide.
Job SummaryResponsible for providing or overseeing the analysis, administration, and oversight of comprehensive chemistry/biochemistry policies, programs, and practices. May advise clients on the analysis of materials, products, and devices, design and qualify analytical methodologies for small molecules and biologics in early‑stage clinical trials, and interpret analytical data to guide formulation and process development decisions.
Essential Functions- Lead and train staff, providing work direction, guidance, and training.
- Oversee the preparation, review, and processing of forms, documents, databases, and related materials.
- Maintain proper documentation of practices following GxP and QC procedures.
- Perform complex, specialized analysis of materials, products, and devices using analytical instrumentation and standard operating procedures.
- Analyze and review results, determine trends, draw conclusions, and present findings, proposals, and recommendations to management and/or clients.
- Provide training and guidance on analytical tests, methods, and instrumentation as required.
- Assist with development or participation in chemistry/biochemistry/formulation or cross‑functional projects, including budgets, timelines, and resources.
- Develop, validate, and transfer analytical methods; conduct routine and non‑routine analysis using HPLC, ddPCR, ELISA, and various bioassays.
- Design and develop robust, scalable formulations for small molecules and biologics in early‑stage clinical trials.
- Ensure adherence to SOPs, regulatory guidelines, GLP, and GMP standards.
- Develop critical material qualification protocols and maintain an up‑to‑date inventory of critical materials.
- Contribute to departmental efficiency by suggesting improvements and actively participating as a team member.
- Promote a harmonious and effective workplace environment and support the overall mission of Pace Analytical.
Education and Experience
- Bachelor's degree in chemistry, biochemistry, or a closely related field.
- 5‑8 years of experience in specialized or technical programs or operations, or an equivalent combination of education, training, and experience.
- Master's or PhD strongly preferred.
- Complex, specialized principles, practices, and techniques of chemistry/biochemistry and formulation development.
- Administration and oversight of chemistry/biochemistry programs, policies, and procedures.
- Methods to resolve chemistry/biochemistry problems, questions, and concerns.
- Applicable chemistry/biochemistry laws, codes, and regulations.
- GxP, QC, and ALCOA++ documentation in a PhaseI/PhaseII setting.
- Broad understanding of testing tools, equipment, and calibration.
- Computer applications and systems related to the work.
- Communication skills for interacting with staff, coworkers, and customers.
- Strong business English with correct spelling, grammar, and punctuation.
- Perform complex, specialized chemistry/biochemistry duties (ELISA, ddPCR, Sanger sequencing, CE‑SDS, HPLC).
- Oversee and administer chemistry/biochemistry/formulation functions.
- Operate and train others in analytical instruments and manufacturing equipment.
- Train others in policies and procedures related to the work.
- Manage projects as both a team member and an individual contributor.
- Apply and explain applicable laws, codes, and regulations.
- Prepare advanced functional reports and other written materials.
- Use initiative and independent judgment within departmental guidelines.
- Conduct oral presentations to groups of varying sizes.
- Establish effective working relationships with colleagues and external contacts.
Full‑time roles are eligible for a comprehensive benefits program, which includes competitive salaries, medical, dental, vision, 401(k) retirement savings plan with 100% immediate employer match, life, disability, and voluntary benefits, paid time off for holidays, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage, and identity theft protection.
Equal Opportunity EmployerPace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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