QC Supervisor

Job Title:

QC Supervisor - 3rd Shift (12:00 pm - 8:00 am)

Job Description

The QC Supervisor oversees all quality control laboratory activities on the 3rd shift, ensuring accurate and compliant analytical testing of raw materials, intermediates, in-process controls, stability, and cleaning samples. This role provides analytical support for routine processes and new products, manages laboratory documentation and equipment, and promotes a culture of quality, safety, data integrity, and continuous improvement.

Responsibilities

* Accept full responsibility for managing the quality control laboratory during the 3rd shift and act as the main point of contact on shift.

* Provide analytical support for routine processes and the introduction of new products, ensuring testing meets regulatory and internal quality standards.

* Manage the maintenance and calibration of laboratory equipment, ensuring all instruments remain in a qualified and compliant state.

* Oversee documentation and data management for raw materials, intermediates, in-process controls (IPCs), stability, and cleaning samples.

* Review existing Standard Operating Procedures (SOPs) and SOP Qualifications (SOPQs), and write or update SOPs as needed for new equipment, technologies, or processes.

* Participate in the description and optimization of technical procedures and the review of analytical methods to ensure accuracy, robustness, and compliance.

* Initiate and manage change controls related to documentation, systems, and quality control laboratory processes, ensuring proper impact assessment and implementation.

* Support the introduction and implementation of new work procedures and analytical practices within the laboratory.

* 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, ensuring accuracy, completeness, and compliance prior to approval or rejection decisions.

* Maintain order, cleanliness, and organization within the laboratory to support safe and efficient operations.

* Oversee the entry of analytical data and calculations into the appropriate systems, and ensure accurate printing and control of analytical records and bulletins.

* Control and manage the sample library, including proper storage, traceability, and retention of samples.

* Write, investigate, and document deviations, Out of Specification (OOS), Out of Trend (OOT), Out of Expectation (OOE), and other laboratory events in a timely and thorough manner.

* Promote and ensure compliance with Health, Safety, and Environment procedures, as well as quality, Good Manufacturing Practice (GMP), and Data Integrity requirements.

* Apply ALCOA and ALCOA+ principles to all data handling activities, ensuring data are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

* Support and promote continuous improvement initiatives by identifying opportunities to optimize laboratory processes and resource utilization, and by helping to define and implement improvement actions.

* Collaborate with other shifts and quality stakeholders to ensure consistent practices, smooth handovers, and alignment with overall quality objectives.

* Provide guidance and day-to-day oversight to 3rd shift QC analysts, supporting their technical development and adherence to procedures.

Qualifications

* Degree in a scientific discipline, preferably in Chemistry or Pharmacy.

* Minimum of 3 years of chemistry laboratory experience in a GMP-regulated environment such as pharmaceutical, medical device, food, chemical, or related industries.

* Strong practical experience in analytical chemistry techniques, including wet chemistry methods.

* Hands-on experience with High Performance Liquid Chromatography (HPLC) in a GMP laboratory setting.

* Experience working with raw materials, intermediates, IPCs, stability samples, and cleaning samples in a regulated QC environment.

* Solid understanding of GMP principles and quality systems within pharmaceutical or related industries.

* Knowledge and application of data…