QA Specialist- Biotech

Under general supervision and guidance, responsible for supporting maintenance of the quality management system (QMS). Responsibilities include nonconformance and deviation management, CAPA support, document and change control activities, audit support, maintaining and refining QMS processes, supporting training initiatives, and shepherding corrective actions through to completion.

• Develop working knowledge of the QMS and provide guidance to manufacturing and support teams appropriate to role level.
• Review batch records and perform product release activities.
• Review cGMP documentation and manage document control and archival processes.
• Provide QA on-the-floor support during manufacturing operations.
• Support investigation and resolution of deviations and nonconformances affecting in-process and finished products.
• Support internal and external audits, including preparation and follow-up activities.
• Initiate and support change control activities in collaboration with departmental Subject Matter Experts (SMEs).
• Perform risk assessments, document investigations, and author or support corrective and preventive tasks.
• Perform incoming inspection and release of raw materials and consumables.
• Maintain compliance with ISO 13485:2016 and applicable FDA Quality System Regulations (21 CFR Part 820).
• Support continuous improvement initiatives within the Quality function.
• Support the strategic priorities of the Company and Quality function.
• Assist with any additional Quality‑delegated tasks.

• Strong interpersonal, written, and communication skills.
• Ability to follow written instructions and perform tasks with direct or minimal supervision.
• Effectively works independently, as well as in a team environment.
• Detail‑oriented and ability to multitask.
• Microsoft Office (i.e., Word/Excel/ PowerPoint) Proficient.
• Net Suite, SAP, or similar ERP programs highly desirable.
• Ability to critically analyze datasets, draw meaningful conclusions, and identify next questions or data gaps.
• Ability to synthesize complex or abstract concepts into structured, actionable insights.
• Resourceful problem‑solver with the ability to independently identify solutions and leverage available tools and information effectively.
• Strong desire to learn, grow, and continuously expand technical and professional skillsets.

• Bachelor's degree in a related life science or technical discipline.
• 1–3 years of experience in a regulated manufacturing, medical device, biotechnology, or pharmaceutical environment (QC or manufacturing experience acceptable).

• Bachelor's degree in a related life science or technical discipline.
• 3–5 years of progressive experience in a regulated manufacturing, medical device, biotechnology, or pharmaceutical environment.
• Demonstrated experience independently managing deviations, CAPAs, or change controls.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.