QC Supervisor

This role oversees all quality control laboratory activities on the 3rd shift, ensuring accurate analytical support for routine processes and new products in a regulated GMP environment. The QC Supervisor is responsible for laboratory management during the shift, including equipment oversight, documentation control, and approval or rejection of materials and samples.

Responsibilities

• Manage the QC laboratory during the 3rd shift and serve as the primary senior point of contact for all quality control activities.
• Oversee the maintenance and calibration of laboratory equipment to ensure accurate and reliable performance.
• Manage documentation related to raw materials, intermediates, in-process controls (IPCs), stability, and cleaning samples in accordance with GMP and data integrity requirements.
• Review existing standard operating procedures (SOPs) and SOP qualifications (SOPQs), and write or update new procedures to reflect new equipment, technologies, and methods.
• Participate in the description of technical procedures and the review of analytical methods, ensuring they are current, clear, and compliant.
• Initiate and manage change controls in documentation and systems, including quality control laboratory reports and related records.
• Support the introduction and implementation of new work procedures within the laboratory, ensuring proper training and adherence.
• Approve or reject raw materials, intermediates, IPCs, stability samples, and cleaning samples based on analytical results and applicable specifications.
• Prepare and review analytical records in accordance with current SOPs and SOPQs for subsequent approval or rejection decisions.
• Maintain order, cleanliness, and organization within the laboratory to support safe and efficient operations.
• Oversee data entry and calculations in laboratory systems, ensuring accuracy and completeness, and generate analytical records and bulletins as needed.
• Control and maintain the sample library, ensuring proper storage, traceability, 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, documenting root causes and corrective actions.
• Promote and ensure compliance with Health, Safety and Environment procedures, quality systems, GMP requirements, and data integrity principles following appropriate training.
• Encourage and implement continuous improvement initiatives by identifying opportunities to enhance efficiency, resource utilization, and process robustness in the laboratory.
• Collaborate with laboratory leadership and cross-functional teams to support ongoing projects and customer work, aligning shift activities with broader organizational goals.

Requirements

• Degree in Sciences, preferably in Chemistry or Pharmacy.
• At least 3 years of chemistry laboratory experience in a GMP environment (such as food, pharmaceutical, medical device, or chemical industries).
• Strong knowledge of analytical chemistry and wet chemistry techniques.
• Hands-on experience with high-performance liquid chromatography (HPLC).
• Experience with gas chromatography (GC) and related chromatographic techniques.
• Familiarity with stability testing, raw material testing, intermediates, and in-process controls (IPCs).
• Working knowledge of GMP regulations and pharmaceutical or related industry quality systems.
• Understanding and application of data integrity principles, including ALCOA and ALCOA+.
• Experience performing data review, including audit trail review and verification of analytical results.
• Ability to approve or reject raw materials, IPCs, stability samples, and cleaning samples based on defined specifications.
• Proficiency with Microsoft Excel and Word for documentation, reporting, and data handling.
• Training or demonstrated knowledge in Health, Safety and Environment practices within a laboratory setting.
• Ability to write, review, and follow SOPs and laboratory procedures accurately.
• Strong attention to detail, organizational skills, and ability to maintain rigorous documentation.
• Capability to work independently on a night shift while providing leadership and guidance to other analysts.

Pay

The pay range for this position is $34.00 - $40.86/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance.
• Critical Illness, Accident, and Hospital coverage.
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents).
• Short and long-term disability.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation, or Sick Leave).

Schedule

This is a 3rd shift, fully onsite position in Morton Grove, IL. The role is a Contract to Hire opportunity.