Biotech Quality Assurance Specialist
The responsibility of the Quality Assurance Specialist is to provide Quality Assurance oversight of clinical manufacturing of final drug product and identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures.
- Review and approve master batch records, labels, specifications and other pre-production documents for clinical APIs in compliance with FDA and international health agency requirements.
- Review technical information provided by client for formulation process and components capability which will be used for the preparation of the batch record.
- Review executed production batch records, manufacturing (i.e. logbooks, equipment records and WFI charts), environmental monitoring data, analytical data, quality control data for in-process and finished products and associated documentation, including any deviation and investigation reports related to lot release of clinical APIs in support of product disposition.
- Review all aspects of pharmaceutical manufacturing and identify any deficiencies.
- Reviews environmental monitoring, WFI and Air Flow Velocity trending reports.
- Responsible for grading the visual inspection tests, reviewing and approving rinse water samples.
- Responsible for sampling of chemicals and providing laboratory with EP/USP monographs.
- Responsible for reviewing, tracking and submitting EM samples to contract laboratory for organism ID.
- Perform quality investigations of manufacturing Deviations, cGMP and Quality System issues, and non-conforming materials.
- Responsible for the release of all raw material and manufacturing supplies (critical components) including auditing them for retention against record, completeness and accuracy.
- Responsible for the release of manufacturing area clearance for the initiation of new filling projects.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
- Perform annual product quality reviews and system reviews as assigned.
- Interfaces with contract manufacturers to address documentation and compliance issues.
- An accountable team player and leader who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures.
- Ability to work independently and effectively train Quality Assurance members in a high-paced environment with tight timelines, while maintaining accuracy and quality.
- Familiar with computers and software programs utilized for the generation of analytical data.
- Successful in organizing, scheduling, following through and meeting deadlines on work assignments.
- Work produced is accurate and thorough.
- Perform other related duties and responsibilities as assigned.
- Bachelor's Degree in chemistry, biology, or biochemistry and five (5) to seven (7) years of experience in the same or closely related cGMP environment.
- Demonstrated competence in QA related activities through education and experience.
- Demonstrated ability to work under minimum supervision; exhibit leadership skills to coordinate personnel and projects on various levels.
- Excellent oral and written communication skills are required.
- Experience in sterile product manufacturing is a must.
PYRAMID Laboratories, Inc. (PYRAMID) is a rapidly growing Contract Aseptic Manufacturer and Analytical Service provider for the pharmaceutical and biotechnology industries.
PYRAMID offers a wide array of services for all phases of drug development, including:
Formulation & Process Development
Lyophilized Product Formulation & Cycle Development
Product Process Validation
Clinical and Commercial Vial & Syringe fill / finish
Clinical and Commercial Lyophilization batches
Labeling & Packaging
Analytical Quality Control Laboratory Services
Analytical Method Development & Validation
API & Drug Product Stability Studies
Costa Mesa, CA
Thu, 31 Aug 2017 16:35:19 PDT