Quality Assurance Associate
QUALITY ASSURANCE ASSOCIATE: ANALYTICAL AND MANUFACTURING SUPPORT
The Quality Assurance Associate assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC.
Essential Job Functions:
1. Analytical Support – Support functions include, but are not limited to: review and approval of in-process testing, release testing of products, stability testing, other data summaries, method validation data, laboratory equipment validation protocols, product certificates of analysis, generation of environmental chamber monitoring reports. Other duties as deemed appropriate by Head of Quality.
2. Manufacturing Support - Support functions for manufacturing including, but are not limited to, line clearances, review and approval of raw material specifications and testing/inspections, review and approval of draft and executed batch records, review of environmental monitoring data, review/approval of GMP warehouse temperature charts for refrigerators, freezers and temperature/humidity charts for the warehouse itself. Other duties as deemed appropriate by Head of Quality.
3. Document Control – Support functions for Document Control include, but are not limited to, issuance of all QA assigned numbers, creation and issuance of logbooks, routing and tracking of new and revised documents for approval, filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure. Communication with clients for review and approval of controlled documents. Other duties as deemed appropriate by Head of Quality.
4. Internal Audits and Client / Regulatory Audits – Support functions include execution of assigned internal audits, authoring of observations, coordinating with audited department personnel on corrective actions, and finalization and close out of audit reports. Client and Regulatory audit functions include facility tours, retrieval of GMP documentation, and implementation of corrective actions (as needed). Other duties as deemed appropriate by Head of Quality.
3. Equipment and Facilities Calibration, Maintenance, Validation, Preventive Maintenance – Responsibilities may include, but are not limited to, ensuring that the GMP equipment tracking system (Blue Mountain) is continuously updated and maintained, sending out notifications to department equipment owners for calibration, maintenance, PM, validation. Other duties as deemed appropriate by Head of Quality.
The Quality Assurance Associate is responsible for compliance with all safety regulations:
Mechanical/Electrical/Fire Hazards encountered in Manufacturing/Laboratory Areas
5. Contact with others:
Internal contact includes daily contact with all personnel and regular contact with management.
External contact may require infrequent contact with Clients.
Bachelor’s degree in chemistry or a related field.
3+ years experience within the US pharmaceutical industry or laboratory experience.
Solid knowledge of chromatography. Ideally 3+ years' experience with HPLC.
Knowledge of other chemical laboratory equipment.
Familiar with a variety of the field's concepts, practices, and procedures, and the regulatory framework within which the pharmaceutical industry operates.
The following are examples of exceptional skills which may be used as a guide for achievement and consideration for advancement:
- Detailed attention in job performance
- Improvement on the quality system
- Good attitude, work ethic and natural leadership
- Achievement of an advanced degree or certification
- Excellent written and verbal communication