Quality Control Specialist
The Quality Control Specialist is a pivotal role that collaborates closely with the QA team, working on-site to provide in-process quality assurance expertise for microbiology and chemistry laboratory activities. This position encompasses all Current Good Manufacturing Practices (CGMP) activities and testing, spanning materials, intermediate/finished products, utilities, and facility testing. Working within a team environment, the QC Specialist will ensure meticulous oversight of testing processes, adherence to procedures, compliance standards, and the preservation of Data Integrity. This role involves providing coaching, resolving issues from a QC standpoint, and serving as the primary reviewer of QC data for batch disposition. The QC Specialist's organization, attention to detail, and proactive management of quality events will be integral to the team's success.
Key Responsibilities:
- Collaborate with the QA team to ensure that all testing activities align with relevant procedures and compliance standards, especially within the realms of microbiology and chemistry.
- Provide direct on-the-floor oversight for laboratory activities, including the testing of materials, intermediate and finished products, as well as utility/facility testing. Ensure Data Integrity is upheld at all times.
- Act as the primary reviewer of QC data, contributing to batch disposition decisions and maintaining the highest standards of accuracy.
- Support the development, validation, and transfer of methods, troubleshoot technical challenges, conduct cross-validation studies, and contribute to Installation Qualification/Operational Qualification (IQ/OQ) protocols.
- Maintain thorough documentation of activities using internal reporting mechanisms.
- Monitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples (if applicable), ensuring their proper handling and testing.
- Identify training needs within the QC team and take proactive steps to ensure company-wide compliance and continuous professional development.
- Compile and interpret QC Analytical data, including Out-of-Specification (OOS) instances, and contribute to problem-solving and decision-making processes.
- Ensure that established testing control procedures and good documentation practices are strictly followed throughout the QC laboratory.
- Uphold data integrity and CGMP standards within the QC lab, aligning with the regulatory guidelines prescribed by organizations such as the US Food and Drug Administration (USFDA).
- Ensure the readiness of the QC Laboratory for both internal and external audits, maintaining compliance with regulatory requirements.
- Review equipment and instrument qualification, calibration, preventive maintenance records, and other relevant documentation as assigned.
- Oversee the correct monitoring of equipment, utilities, and facility operations, ensuring that CGMP principles are upheld in all aspects.
- Participate in the review of Tech Transfer activities related to finished products.
- Prepare metrics related to QC Data Review, highlighting trends, efficiencies, and areas for improvement.
Qualifications:
- Bachelor's degree in a relevant scientific discipline (e.g., Microbiology, Chemistry) or equivalent experience.
- Proven experience 6 years in quality assurance, quality control, or related roles within a CGMP environment.
- Strong knowledge of microbiology and chemistry laboratory procedures, methodologies, and equipment.
- Thorough understanding of regulatory requirements and standards, including CGMP and data integrity principles.
- Exceptional organizational skills and keen attention to detail.
- Effective problem-solving and communication skills, both written and verbal.
- Ability to collaborate within cross-functional teams and drive proactive quality initiatives.
- Proficiency in interpreting analytical data and applying insights to decision-making.
- Prior experience with method validation, tech transfer, and equipment qualification is preferred.
- Knowledge of audit preparation and experience in interacting with regulatory authorities is advantageous.
