QA Operations Specialist III - LSA (Dayshift)

About the role

The position is located in Portsmouth, New Hampshire and operates on a 12-hour rotating schedule (7:00 AM – 7:00 PM) with a Monday–Tuesday workday, Wednesday–Thursday off, Friday–Sunday workday pattern.

Responsibilities

• Provide real-time QA support within GMP manufacturing areas, including on-the-floor presence, observation of operations, and review of GMP work practices.
• Perform real-time review of batch records (paper and electronic), logbooks, and other GMP documentation to ensure accuracy and compliance.
• Respond to QA hotline calls, assess quality issues, and make independent, risk-based decisions, escalating as appropriate.
• Guide manufacturing routine and non-routine quality issues, including coaching on GMP requirements and documentation practices.
• Authorize and manage Quality Tag Out activities, including placement and removal in accordance with procedures.
• Identify, assess, and support resolution of deviations and non-conformances, ensuring appropriate escalation and follow-up.
• Serve as a resource and mentor to junior QA staff, providing coaching, training, and support in GMP decision-making.
• Participate in cross-functional meetings and initiatives, representing QA and contributing to continuous improvement and inspection readiness.

Requirements

• Bachelor’s degree in life sciences discipline or equivalent experience.
• 5–8 years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong understanding of cGMP, ICH guidelines, and quality systems.
• Working knowledge of manufacturing operations, including upstream/downstream processes, QC, or related functions.
• Experience with quality systems and tools such as TrackWise, SAP, LIMS, Syncade, and Microsoft Office applications.
• Ability to independently assess quality issues, make sound decisions, and appropriately escalate complex situations.
• Strong communication and interpersonal skills, with the ability to provide clear guidance and influence GMP behaviors on the shop floor.
• Experience in drug product manufacturing, QA operations, QC, or environmental monitoring within a GMP environment preferred.

Qualifications

• Bachelor’s degree in life sciences discipline or equivalent experience.
• 5–8 years of experience in a cGMP-regulated pharmaceutical or biotechnology manufacturing environment.

Skills

• Strong technical expertise.
• Sound judgment.
• Ability to operate independently while mentoring others.

Benefits

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Pay

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

Schedule

The schedule operates on a 12-hour rotating pattern with a Monday–Tuesday workday, Wednesday–Thursday off, Friday–Sunday workday pattern.