QC Supervisor (1st Shift Weekends

QC Chemist – 1st Shift Weekends

This QC Chemist role oversees weekend first-shift quality control laboratory operations, providing analytical support for routine processes and new products in a regulated GMP environment. The position carries responsibility for managing laboratory activities during the shift, ensuring accurate testing of raw materials, intermediates, in-process controls, stability, and cleaning samples, and maintaining full compliance with quality, health, safety, environmental, and data integrity standards.

Responsibilities

• Accept responsibility for overall laboratory management and decision-making during the assigned weekend shift.
• Provide analytical support for routine manufacturing processes and the introduction of new products.
• Manage the maintenance and calibration of laboratory equipment to ensure reliable performance and data accuracy.
• Oversee documentation and traceability of raw materials, intermediates, in-process controls (IPCs), stability, and cleaning samples.
• Review existing standard operating procedures (SOPs) and standard operating procedure qualifications (SOPQs) and write new SOPs and SOPQs as required for new equipment, technology, or processes.
• Participate in the description and optimization of technical procedures and analytical methods, including method review and updates.
• Initiate and manage change controls related to documentation, systems, and quality control laboratory reports.
• Support the introduction and implementation of new work procedures and analytical practices in the laboratory.
• Approve or reject raw materials, intermediates, IPCs, stability samples, and cleaning samples in accordance with current specifications and SOPs.
• Create and complete analytical records according to current SOPs and SOPQs to support material and product approval or rejection.
• Maintain order, cleanliness, and good laboratory practices within the QC laboratory.
• Enter analytical data and calculations into the appropriate systems, ensuring accuracy, completeness, and compliance with data integrity principles.
• Generate, review, and print analytical records, bulletins, and related documentation as required.
• Control and manage the sample library, including proper storage, tracking, and retrieval of samples.
• Write and investigate laboratory deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, and other laboratory events, documenting findings and corrective actions.
• Promote and comply with Health, Safety and Environment procedures, quality standards, GMP requirements, and Data Integrity principles after receiving appropriate training.
• Support continuous improvement by identifying, defining, and implementing initiatives that increase efficiency and optimize the use of laboratory resources.
• Collaborate with laboratory management and, over time, provide guidance and direction to other analysts working on the same shift.

Essential Skills

• Minimum of 3+ years of hands-on chemistry laboratory experience in a GMP-regulated environment such as pharmaceutical, medical device, food, chemical, or related industries.
• Strong experience in analytical chemistry and wet chemistry techniques.
• Practical experience with high-performance liquid chromatography (HPLC) in a QC or analytical lab setting.
• Experience working under Good Manufacturing Practice (GMP) regulations and quality systems.
• Ability to perform testing and data review for raw materials, intermediates, in-process controls (IPCs), stability samples, and cleaning samples.
• Working knowledge of gas chromatography (GC) and related chromatographic techniques.
• Understanding and practical application of data integrity principles, including ALCOA and ALCOA+ standards.
• Experience conducting data review, including audit trail review, to ensure completeness, consistency, and accuracy of analytical results.
• Ability to write, follow, and revise SOPs, SOPQs, analytical records, and technical documentation.
• Proficiency with Microsoft Office tools, particularly Excel and Word, for data handling and documentation.
• Ability to investigate and document deviations, OOS, OOT, OOE, and other laboratory events in a structured, compliant manner.
• Degree in a scientific discipline, with Chemistry or Pharmacy strongly preferred.
• Training or familiarity with Health, Safety & Environment requirements in a laboratory setting.
• Ability to manage multiple tasks, prioritize workload, and maintain attention to detail in a fast-paced QC environment.
• Strong written and verbal communication skills for clear documentation and collaboration with cross-functional teams.

Additional Skills & Qualifications

• Experience in pharmaceutical or medical device QC laboratories is highly beneficial.
• Hands-on experience with gas chromatography (GC) and high-resolution gas chromatography (HRGC).
• Familiarity with mass spectrometry and FTIR as part of analytical workflows.
• Experience using chromatography data systems such as Empower, Chromeleon, and Agilent platforms.
• Prior involvement in approvals and…