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Senior Quality Assurance Analyst
2 months ago
About Us
Pace Life Sciences
Pace is dedicated to enhancing global health and safety. We support our pharmaceutical and biopharmaceutical clients throughout the drug development lifecycle, from initial research and development to clinical trials and commercial product support. For clients with internal manufacturing and laboratories, we offer professional services to enhance their operations.
Job Overview
SUMMARY
In this role, you will be accountable for overseeing and conducting comprehensive analyses, administration, and governance of intricate chemistry and biochemistry policies, programs, and practices. You may provide expert feedback and guidance to clients regarding the evaluation of materials, products, and devices, utilizing specialized knowledge in chemistry, biochemistry, formulation development, and related testing methodologies. Responsibilities may include designing and developing effective formulations for small molecules and biologics intended for early-phase clinical trials, as well as optimizing manufacturing processes for drug products. You will also interpret analytical data to inform formulation and process development strategies.
KEY RESPONSIBILITIES
- Lead and mentor staff, providing direction, guidance, and training.
- Oversee and review various forms, documents, databases, and related materials.
- Conduct specialized analyses in support of diverse testing materials and products, adhering to established Standard Operating Procedures.
- Review, analyze, and document testing results, identifying trends and presenting findings to management and clients.
- Deliver training and guidance on analytical methods and instrumentation as necessary.
- Provide expert analysis and counsel to clients and management regarding chemistry and biochemistry policies and practices.
- Assist in developing project objectives, including budgets, timelines, and resource requirements.
- Develop, validate, and transfer analytical methods, performing routine and non-routine analyses using various instruments.
- Ensure compliance with SOPs, regulatory guidelines, and industry standards.
- Contribute to departmental efficiency by actively participating in team initiatives.
- Promote a positive workplace environment through courteous and cooperative interactions.
QUALIFICATIONS
Education and Experience
- Bachelor's degree in chemistry, biochemistry, or a closely related discipline.
- Three to five years of relevant experience, including specialized technical programs; a Master's or PhD is preferred.
Knowledge and Skills
- In-depth understanding of chemistry and biochemistry principles and formulation development techniques.
- Familiarity with the administration of chemistry and biochemistry programs and policies.
- Proficient in resolving complex chemistry and biochemistry challenges.
- Knowledge of applicable laws, codes, and regulations in the field.
- Experience with analytical tools and equipment.
- Proficient in relevant computer applications and systems.
- Effective communication skills for collaboration with team members and clients.
ADDITIONAL INFORMATION
Benefits
We offer a comprehensive benefits package, including paid vacation, holidays, sick leave, medical, dental, and vision insurance, retirement plans with company matching, and various voluntary insurance options.
Equal Opportunity Employer
Pace Life Sciences is committed to providing equal employment opportunities and prohibits discrimination and harassment of any kind.
