QA System Associate-Bioscience
About The Position
The Quality Assurance (QA) Quality Systems Associate supports the Quality Management System (QMS) in a regulated pharmaceutical Active Pharmaceutical Ingredient (API) and medical device component manufacturing environment. The role helps ensure compliance with current Good Manufacturing Practices (cGMP), QMS requirements, and internal procedures to maintain product quality, patient safety, data integrity, and regulatory compliance. The associate supports the Pharmaceutical Quality Management System, quality objectives, continuous improvement, and inspection readiness. The position maintains controlled documentation, monitors deviations and corrective and preventive actions, and supports validation and qualification programs. It also promotes quality culture and compliance across manufacturing and support functions and supports employee training on quality systems.
Requirements
- Associate degree in science or a related field from a regionally accredited four-year college or university, or an equivalent combination of education and experience.
- Excellent writing, interpersonal, and written and verbal communication skills.
- Strong analytical, organizational, and problem-solving skills.
- Professionalism, integrity, accountability, and customer focus.
- Proficiency in Microsoft Office applications.
- Ability to work effectively in a regulated manufacturing environment.
Nice To Haves
- Knowledge and understanding of pharmaceutical quality management systems.
- Prior experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing industries.
- Familiarity with ICH Q7, ICH Q9, 21 CFR Parts 210/211, 21 CFR Part 11, 21 CFR Part 820/QMSR, data integrity, and ALCOA+ principles.
- Experience with electronic QMS, LIMS, ERP, MES, or document management systems.
Responsibilities
- Support compliance with ICH Q7, ICH Q9, ICH Q10, 21 CFR Parts 210 and 211, 21 CFR Part 11, and 21 CFR Part 820/FDA Quality Management System Regulation (QMSR).
- Assist in maintaining an effective Pharmaceutical Quality Management System.
- Support quality objectives, continuous improvement initiatives, and inspection readiness activities.
- Promote quality culture and compliance throughout manufacturing and support functions.
- Maintain controlled documents, including SOPs, specifications, test methods, forms, master batch records, and validation protocols and reports.
- Support document issuance, revision, archival, and periodic review programs.
- Monitor deviations, investigations, CAPA, and nonconformances to ensure timely closure and compliance.
- Support validation and qualification programs, including process validation, PPQ, equipment qualification (IQ/OQ/PQ), cleaning validation, computer system validation (CSV), and analytical method validation.
- Review validation protocols and reports for compliance and completeness.
- Participate in QMS validation execution and documentation review.
- Complete GMP and quality-related training requirements.
- Support employee training on quality systems and compliance requirements.
- Participate in continuous improvement projects focused on quality, compliance, efficiency, and inspection readiness.
- Identify opportunities to improve quality systems and business processes.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
