QA Operations Specialist III - LSA (Nightshift)

About the role

This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

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
• 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

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

• Passionate about quality assurance and regulatory compliance
• Self-motivated and able to work independently
• Excellent problem-solving and critical thinking skills
• Effective communication and collaboration abilities

Skills

• Technical expertise in cGMP and quality systems
• Proficiency in quality management software (TrackWise, SAP, LIMS, Syncade)
• Strong organizational and attention to detail skills
• Ability to handle multiple tasks simultaneously

Benefits

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)

Pay

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

Schedule

This is a 3rd shift position operating on a 12-hour rotating schedule (7:00 PM – 7:00 AM). The schedule follows a rotating pattern of Monday–Tuesday workdays, Wednesday–Thursday off, Friday–Sunday workdays, and continues a biweekly rotation.

Contact Information

If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

Reference: R77307

To apply, please visit our website.