Senior Associate Quality Control (24/7 Shift)

Role Summary

This position as a Senior Associate in Quality Control Analytics involves handling a range of analytical testing and laboratory tasks with minimal supervision. Major activities include HPLC, capillary electrophoresis, gel analysis, characterization, method transfer, sample/data management, and equipment maintenance. The position directly supports manufacturing operations and therefore requires working on a rotating 24/7 shift schedule. Adaptability is essential.

Core Responsibilities

• Perform routine and complex analytical testing with a focus on accuracy and efficiency across various laboratory areas.
• Process, report, and archive analytical data, including evaluating and trending results.
• Handle non-routine methods and a wide variety of assays when required.
• Troubleshoot issues, implement problem-solving measures, and communicate findings to relevant stakeholders.
• Assist in audits, method transfers, assay validations, equipment qualifications, and documentation changes.
• Initiate, develop, and introduce new testing techniques and ensure continuous improvement in lab practices.
• Participate in regulatory filings, lab investigations, and project-focused initiatives within and beyond the department.
• Provide technical guidance, training, and support to team members as necessary.

Knowledge & Expertise Required

• Solid grasp and hands-on application of GMP standards in a QC analytical laboratory setting.
• Experience with regulatory compliance and industry requirements for pharmaceutical GMP manufacturing/testing.
• Proficiency in a variety of analytical techniques: HPLC, Capillary Electrophoresis, UV spectrometry, and density testing.

Required Skills

• Ability to analyze technical problems and develop moderately complex solutions.
• Strong written and verbal communication, with technical documentation and presentation proficiency.
• Effective project management, organization, and prioritization skills to meet laboratory and regulatory goals.
• Capable of guiding, coaching, and training others on procedures and best practices.
• Competent with data analysis tools for statistical trending and interpretation.
• Sound decision-making, influence, and negotiation abilities.

Additional Information

• This position is part of an onsite 24/7 shift pattern supporting active manufacturing operations.
• The ideal candidate is adaptable and able to work independently while delivering high-quality results the first time.
• May represent the department for cross-team or regulatory interactions.

Education and Experience

• Bachelor’s degree in a science discipline.
• At least 5 years of experience in biopharmaceutical QC or equivalent GMP laboratory roles in pharma or medical devices.