Quality Operations Specialist - II (Associate)

Join a world-class Quality Control group dedicated to ensuring that every product manufactured, processed, and distributed meets incredibly high standards of excellence and regulatory compliance. As a Shift Supervisor, you will lead a team of laboratory technicians within an interdependent global manufacturing network focused on delivering a reliable supply to patients on time, every time. This role is highly hands-on, requiring a leader who can navigate a complex analytical environment featuring advanced instrumentation like HPLC, UPLC, and GC. If you are a decisive professional ready to oversee critical in-process and water sample testing in a fast-paced, 12-hour rotating shift environment, this position offers the opportunity to safeguard product integrity at every stage of the supply chain.

Responsibilities

• Supervise and mentor a team of laboratory technicians performing analytical testing on in-process and water samples.
• Perform critical second-person reviews of laboratory work, including GC, TOC, conductivity, and microbial filtration results.
• Review and approve both paper-based documentation and electronic records to ensure absolute data integrity and GMP compliance.
• Provide direct technical support by performing microplate assay testing and troubleshooting laboratory instrumentation.
• Oversee the daily operation of analytical tools including KF, IR, HPLC, UPLC, and turbidimetric spectroscopy.
• Utilize and manage laboratory data systems such as Empower, LIMS, and various stand-alone data acquisition software.
• Ensure all laboratory activities align with high quality standards and stringent regulatory requirements.
• Coordinate laboratory workflows to maintain testing timelines during 12-hour rotating shifts.
• Facilitate effective communication between shifts and cross-functional manufacturing partners to ensure seamless transitions.
• Exercise strong decision-making skills to resolve laboratory issues and maintain a compliant, efficient testing environment.

Education

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific discipline.

Experience

• Minimum of two years of quality or laboratory experience within the Pharmaceutical industry (or an advanced degree in a relevant field).
• Demonstrated experience with laboratory instrumentation and hands-on bench testing.
• Previous experience with laboratory data management systems (LIMS, Empower) is highly preferred.
• Proven proficiency in operating and troubleshooting complex analytical equipment.

Additional Information

• Shift Schedule: This position operates on a 12-hour rotating shift (7am–7pm and 7pm–7am), including third-shift and weekend coverage.
• Safety Note: Candidates must be comfortable working in an environment with potential beta-lactam antibiotic exposure.
• Core Competencies: Requires excellent communication skills and the ability to make sound technical decisions under pressure.