QA Specialist II - Operations
On-sitePortsmouth, New Hampshire, United States
Job Summary
Conduct daily QA presence in GMP operational areas to review documentation and observe practices while partnering with Manufacturing teams to ensure compliance with GMP standards and data integrity principles. Provide guidance and coaching on GMP behaviors, support inspection readiness, and independently make routine GMP-related decisions or escalate complex issues to senior staff. Respond to QA Hotline calls, manage equipment status including Quality Tag Outs, and represent Quality Assurance in cross-functional meetings to maintain facility state of inspection readiness. Operate on a 3rd shift rotating schedule (7:00 PM – 7:00 AM) at the Portsmouth, NH office.
Required Qualifications
- Associate or bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, or related field)
- Basic understanding of cGMP regulations and good documentation practices
- Familiarity with manufacturing process steps and quality control activities within a regulated environment
- Awareness of product clearance and line clearance requirements during manufacturing operations
- Experience following standard operating procedures (SOPs) and completing required documentation accurately
- Ability to recognize potential compliance issues and communicate concerns to supervisors or appropriate team members
- Strong attention to detail and the ability to identify unusual events or conditions and escalate appropriately
- Effective communication and organizational skills with the ability to work collaboratively in a team environment
- Ability to prioritize routine tasks and work effectively under general supervision
- Must be available for a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM)
- Must be based in the Portsmouth, NH office
Desired Qualifications
- Associate or bachelor's degree in a scientific or engineering discipline (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, or related field) preferred
- Familiarity with manufacturing and quality systems such as SAP, LIMS, TrackWise, Syncade, or similar systems preferred
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