Specialist II, Quality Assurance
About The Position
We are seeking a detail-oriented and proactive Quality Assurance Specialist II to support the Quality Management System, ensure adherence to cGMP regulations, and foster continuous improvement across operational, validation, maintenance, and laboratory functions. The role contributes to maintaining high standards of quality and compliance and involves authoring and approving quality documentation, leading CAPA initiatives, tracking quality-system activities, and providing compliance guidance. The company describes a supportive environment that values professional development and recognizes employees’ contributions.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- 2–4 years of experience in Quality Assurance within a regulated environment.
- Proficient knowledge of Microsoft Office (Word, Excel, Outlook), web browsers, barcoding systems, and electronic Quality Management Systems (eQMS), with the ability to learn new software quickly.
- Strong knowledge of cGMP regulations, quality systems, and validation processes.
- Proven ability to author, review, and approve quality documentation and records.
- Excellent organizational skills and ability to manage multiple projects simultaneously.
- Strong written and verbal communication skills.
- Detail-oriented with a focus on accuracy and compliance.
- Ability to work independently and collaboratively within a team.
Nice To Haves
- Experience in the pharmaceutical or biotech industry.
Responsibilities
- Independently author, revise, review, and approve Standard Operating Procedures (SOPs), Client Operating Protocols (COPs), policies, and training materials.
- Author, review, and approve GMP and non-GMP records, including preventative maintenance, pest control, and facility walk-through documentation.
- Lead Corrective and Preventive Action (CAPA) initiatives, including authoring, tracking, and verifying the effectiveness of CAPA activities.
- Track and drive completion of assigned Quality Management System functions in accordance with cGMP, regulations, and company standards.
- Provide support, guidance, and recommendations regarding compliance of operational, validation, maintenance, and laboratory tasks.
- Ensure timely completion of quality-related activities and escalate issues as necessary to maintain compliance and quality standards.
Benefits
- Professional development opportunities
- Supportive work environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
