QC Supervisor

QC Supervisor (3rd Shift)

The QC Supervisor oversees all quality control laboratory activities on 3rd shift (12:00 a.m. 8:00 a.m., Monday through Friday). This role manages laboratory operations, ensures accurate and compliant analytical testing, and provides technical support for routine processes and new products within a regulated GMP environment.

Responsibilities

• Accept full responsibility for managing the quality control laboratory during the assigned shift.
• Provide analytical support for routine processes and new product introductions in accordance with GMP requirements.
• Manage the maintenance and calibration of laboratory equipment to ensure accurate and reliable performance.
• Oversee documentation of raw materials, intermediates, in-process controls (IPCs), stability and cleaning samples, ensuring accuracy and compliance.
• Review existing standard operating procedures (SOPs) and SOPQs and write new procedures as needed for new equipment, technologies, or processes.
• Participate in the description and optimization of technical procedures and the review of analytical methods.
• Initiate and manage change controls related to documentation, systems, and quality control laboratory reports.
• Support the introduction and implementation of new work procedures in the laboratory.
• Approve or reject raw materials, intermediates, in-process controls, stability samples, and cleaning samples based on analytical results and established criteria.
• Ensure timely and accurate equipment maintenance and calibration activities are documented and completed.
• Prepare and review analytical records in accordance with current SOPs and SOPQs for approval or rejection decisions.
• Maintain order, cleanliness, and organization within the laboratory to support efficient and safe operations.
• Oversee data entry and calculations in laboratory systems, ensuring accuracy and completeness, and generate analytical records and bulletins as required.
• Control and manage the sample library, including proper storage, tracking, and retrieval of samples.
• Write and investigate deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, and other laboratory events, ensuring thorough documentation and follow-up.
• Promote and ensure compliance with Health, Safety and Environment procedures, quality standards, GMP systems, and Data Integrity principles after receiving appropriate training.
• Support and drive continuous improvement by identifying, defining, and implementing initiatives that increase efficiency and optimize the use of available resources.
• Collaborate with laboratory leadership and other stakeholders to ensure alignment with organizational quality and operational goals.
• Provide guidance and day-to-day leadership to a small team of analysts on 3rd shift, fostering a culture of quality, safety, and continuous improvement.

Essential Skills

• Degree in Sciences, preferably in Chemistry or Pharmacy.
• Minimum of 3+ years of chemistry laboratory experience within a GMP environment (such as food, pharmaceutical, medical device, or chemical industries).
• Strong knowledge of analytical chemistry principles and laboratory practices.
• Hands-on experience with wet chemistry techniques.
• Practical experience with high-performance liquid chromatography (HPLC).
• Experience with gas chromatography (GC) and related chromatographic techniques.
• Understanding of GMP regulations and quality systems in a regulated environment.
• Experience working with raw materials, intermediates, in-process controls (IPCs), stability samples, and cleaning samples, including approvals and rejections.
• Familiarity with data review and data integrity requirements, including ALCOA and ALCOA+ principles and audit trail review.
• Training in Health, Safety and Environment practices applicable to laboratory operations.
• Training on analytical techniques such as HPLC, HRGC, GC, FTIR, and related methods.
• Proficiency with Microsoft Office applications, particularly Excel and Word.
• Ability to write, review, and implement SOPs and other controlled documentation.
• Experience investigating deviations, OOS, OOT, OOE, and laboratory events and documenting findings clearly.
• Strong attention to detail, organizational skills, and ability to manage multiple tasks in a fast-paced environment.
• Ability to work independently on a night shift while providing guidance to other analysts.

Additional Skills & Qualifications

• Experience in a pharmaceutical or medical device QC laboratory environment.
• Familiarity with chromatography data…