Om jobbet
The Quality Assurance Senior Specialist is an experienced professional level position responsible for quality assurance activities associated with cGMP manufacturing, documentation, and product disposition. Ensures that proper controls are followed and maintained during the manufacturing, processing, packaging, and warehousing of compounded products.
Din profil
Basic Qualifications
- College Degree and at least eight to ten years cGMP experience in a pharmaceutical manufacturing company or equivalent combination of education and cGMP experience in a required.
- Experience with quality systems, aseptic technique, cGMP document review, quality investigations, CAPA, Change Control and MasterControl preferred.
- Proficient in MS Office programs, including Word and Excel.
- Ability to process information rapidly from multiple sources and communication channels.
- Ability to handle a high volume of work and rapidly adapt to changing environment.
The What?
- Execute and develop proficiency in all Level 1, Level 2, and Level 3 Quality Assurance tasks:
- Level 1:
- Manufacturing / Packaging Line Clearances
- Product Label Review and Approval
- Product Label Reconciliation
- EMS Data Review
- Logbook Review and reconciliation
- Level 2:
- Batch Record Issuance
- Batch Record Review and Approval
- Incoming Material Review and Approval
- Form and Logbook Issuance
- Review and Approval of Testing Data
- Review and Approval of Event Reports and Associated Corrective Actions
- Level 3:
- Disposition and Release of Incoming Materials
- Disposition and Release of Finished Product
- Document Control Activities
- Review and Approval of Change Controls and controlled document changes
- Review and Approval of Moderate Risk Deviations
- Demonstrated Subject Matter Expertise in at least two QA functions.
- Takes on QA projects of low to moderate complexity as assigned.
- Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
- Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
- Assist with problem identification and resolution efforts for quality related issues associated with the compounding operations.
- Assist with internal, corporate, 3rd party and federal/state inspections and audits.
- Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
- Ensure cGMP documentation associated with work activities meets ALCOA standards.
- Maintain assigned training standard operating procedures.
- Perform other related duties as assigned.
Vi tilbyder
- Maintain the Fagron Family Values of Quality, Customer is #1, Transparency, Entrepreneurship, Creativity, and Speed of Execution while performing job responsibilities.
- Follow Fagron Family Rules
- Contribute to QA Team success by participating in problem solving discussions and seeking to understand the “Why?”
- Strive for continual learning and improvement
- Develop Subject Matter Expertise (SME) in two or more QA functional areas (e.g., Doc Control, Release, QC Support, and etc.)
- Lead by example for more junior QA staff.