QC Lab Supervisor (1st Shift Weekends)

Actalent; Illinois; On-site; USD 70,000 - 100,000; Full time

Job summary

Actalent is seeking a QC Lab Supervisor for the 1st shift on weekends, overseeing laboratory operations in a GMP environment. You will manage testing of raw materials, intermediates, IPCs, stability, and cleaning samples while ensuring data integrity and compliance.

The role requires directing analysts, refining SOPs, and maintaining equipment calibration. The ideal candidate has a chemistry background, 3+ years of GMP lab experience, and proficiency with HPLC and data review.

Qualifications

• 3+ years hands-on chemistry lab experience in GMP settings.
• Proficiency in HPLC in QC/analytical labs.
• Familiarity with ALCOA/ALCOA+ data integrity.
• Experience with GMP regulations and quality systems.
• Ability to write and revise SOPs/SOPQs.

Responsibilities

• Oversee weekend first-shift lab operations and decision-making.
• Provide analytical support for routine manufacturing and new products.
• Maintain calibration and maintenance of lab equipment for data accuracy.
• Manage documentation for raw materials, IPCs, stability, and cleaning samples.
• Review and write SOPs/SOPQs for new equipment or processes.
• Support method development and validation activities.
• Initiate change controls for documentation and QC reports.
• Promote health, safety, and data integrity standards.

Skills

Analytical chemistry

GMP experience

Data integrity

SOP writing

Documentation

Education

Bachelor's degree in science

Tools

HPLC

GC

Excel

Word

Job description

Job Description

Job Description

Job Title: QC Lab Supervisor – 1st Shift Weekends

Job Description

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.

Qualifications

• Bachelor's Degree in a Scientific Discipline
• 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.