Associate Scientist, Quality
About The Position
The Associate Scientist, Quality supports quality assurance and quality control operations for the insourced laboratory team as part of an End-to-End (E2E) Laboratory Modernization Program. Depending on assignment, this role concentrates in one or more of the following areas: CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions operate as a single Quality team, staff routinely support one another across these areas as workload requires. This role operates within an ISO 17025 accredited analytical production laboratory at a client site. This is an entry-level position: the Scientist performs the activities above under direct supervision while developing foundational technical proficiency.
Requirements
- Strong understanding of CAPA principles, deviation management, and root cause analysis techniques.
- Knowledge of document control, records management, and metrology/calibration program requirements.
- Ability to coordinate training programs and competency assessments.
- Knowledge of ISO 17025 quality systems and regulatory requirements.
- Excellent organizational skills, technical writing, and documentation review capabilities.
- Effective communication and cross-functional collaboration skills.
- Strong attention to detail and commitment to data integrity principles.
- Bachelor’s degree in chemistry, biology, or related scientific discipline with 0–2 years of relevant experience.
- OR Associate degree with 2+ years of relevant quality or laboratory experience.
- Demonstrated ability to work collaboratively under close to direct supervision in a regulated laboratory environment.
- Adaptable, self-motivated, and capable of following detailed instructions and completing routine tasks.
Nice To Haves
- Experience managing CAPA systems and non-conformance investigations, including root cause analysis and continuous improvement methodologies.
- Experience supporting document control systems, records management, and electronic document/records platforms.
- Experience coordinating calibration and equipment maintenance programs; familiarity with metrology software and asset management systems.
- Experience developing or coordinating training programs and maintaining competency/qualification records; familiarity with learning management systems.
- Experience within ISO 17025, GLP, GMP, or FDA-regulated environments.
- Familiarity with LIMS and electronic documentation platforms.
Responsibilities
- Coordinate and manage CAPA activities associated with laboratory deviations, non-conformances, audit findings, and customer observations; lead or support root cause investigations using established quality methodologies.
- Maintain controlled documents, including SOPs, work instructions, forms, and quality records, and coordinate revisions, approvals, archival, and retention requirements.
- Coordinate calibration and maintenance activities for laboratory instrumentation, maintain equipment qualification and calibration records, and ensure measurement traceability.
- Perform scanning, indexing, and electronic filing of laboratory records and quality documents; support records retrieval and archival activities.
- Coordinate laboratory training programs, maintain training records, and support onboarding, qualification, and competency assessments for laboratory personnel.
- Track CAPA records, calibration schedules, and training compliance to ensure timely completion and effectiveness.
- Review documentation for completeness, accuracy, and compliance with quality requirements across CAPA, document control, metrology, records, and training activities.
- Support internal and external audits, inspection readiness, and regulatory compliance activities across all quality functions.
- Facilitate cross-functional discussions involving laboratory personnel, quality representatives, and stakeholders.
- Identify opportunities to improve quality systems and streamline processes across CAPA, document control, metrology, records management, and training.
- Maintain training and compliance in health, safety, environmental, and operational requirements.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401k
- Paid holidays
- Employee discount programs
- Professional development
- Learning and development program
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
