Prolacta Bioscience is seeking a QC Compliance Specialist, fully competent to serve as a technical resource and contributor in one or more specialized functions. The QC Compliance Specialist is required to support in the development and implementation of compliance programs for the organization and the monitoring of business activities for compliance with applicable rules and regulations (i.e. support quality and regulatory compliance for testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling). Additionally, the QC Compliance Specialist is required to support simple to moderately complex, OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigations. This role is required to work closely with and support each of these systems as they relate to the testing performed for Prolacta.
Primary Duties and Responsibilities- In-depth understanding and adherence to the Quality System requirements established by Prolacta Bioscience
- Demonstrates broad understanding of routine laboratory procedures
- Demonstrates working knowledge of project/process flow within discipline
- Applies technical expertise and has moderate knowledge of other related business disciplines/policies
- Identifies areas for continuous improvements and efficiencies
- Evaluates, selects, and applies standard techniques and procedures
- Responsible for ensuring QC compliance with all Federal, State, local and company regulations, policies, and procedures related to EHS (Environment, Health and Safety) practices
- Develop, maintain and report statistical analysis and metrics of QC data
- Identify emerging trends in laboratory compliance (i.e. FDA, ICH, compendial revisions and laboratory safety), corporate practices, policies, and procedures
- Identify gaps in corporate practices, policies, and procedures
- Ensures operating manuals and procedural documents stay current when regulations change
- Work closely with staff on OOS, NC, LIR, OR, CA and/or CAPA investigations, reports, and root cause analysis for all testing that occurs within the Prolacta and contract laboratory for GMP production, studies, and investigations
- Utilizes significant knowledge of raw materials and finished goods testing in preparing conclusions and recommendations
- Work closely with Quality Assurance (QA) to support and ensure inspection readiness in the laboratory for QA Walk-Throughs
- Work closely with the QA Training Specialist as needed to provide necessary technical support for the training program pertaining to the QC department
- Provide the support required to generate installation/operation/performance qualifications for QC analytical instrumentation
- Ensure QC instruments and equipment are calibrated and maintained
- Support the development and execution of validation studies and research projects
- Works on simple to moderately complex projects requiring evaluation of materials testing
- Provides leadership, guidance, and training to junior colleagues on a regular basis