QA Operations Specialist III - LSA

Location: This is a 1st shift position operating on a 12-hour rotating schedule (7:00 AM – 7:00 PM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

What you will get:

Below you will find a comprehensive summary of the benefits package we offer:

• 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).

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

What will you do:

We are seeking an experienced QA Operations Specialist III to provide real-time quality oversight and on-the-floor support for GMP manufacturing operations. This role serves as a key quality presence within operational areas, ensuring compliance, supporting decision-making, and driving high standards of GMP execution. The ideal candidate brings strong technical expertise, sound judgment, and the ability to operate independently while mentoring others.

• 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

• Provide guidance to 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

What we are looking for:

• 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