Quality Assurance (QA) Assistant, San Diego, CA
Job Duties and Responsibilities:
- Assist Quality Management with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
- Assist with training employees on GMP requirements as well as specific procedures.
- Responsible for implementing and maintaining inventory system for controlled temperature material storage.
- Responsible for coordinating shipments for in-process samples, final products, and R&D samples to clients as well as contract testing facilities and other organizations.
- Responsible for operational maintenance log books; equipment, shipments, etc.
- Responsible for maintaining the equipment and calibration programs.
- Prepare monthly equipment calibration lists, including contacting service providers, obtaining quotes, scheduling appointments, and updating equipment files accordingly.
- Provide assistance in maintaining company¿s preventive maintenance programs for equipment used in GMP Production.
- Review Calibration and Preventive Maintenance Records.
- Track and Investigate equipment out of tolerance reports (OOTs), Deviations and CAPAs.
- Assists management with client¿s on-site audits.
- Serve as a backup operator for routine and in-process Environmental Monitoring of the GMP production facilities and during aseptic filling operations.
- Initiate and participate in the investigations into Environmental Monitoring excursions and assess any potential impact.
- Assist with the batch record review process to ensure the proper evaluation before the release of lots.
- Provide support to Manufacturing Department in line and equipment clearance activities.
- Write, revise, and follow Standard Operating Procedures in accordance with cGMPs.
- Perform other duties as required.
- High school diploma, or equivalent.
- One (1) year of experience in a quality-related position.
- Preferred one (1) year experience in a manufacturing or biology environment.
- Knowledge of basic business software programs, such as Microsoft Office Suite.
- Ability to use available research tools to conduct basic research.
- Ability to maintain positive demeanor in a continually changing, multi-task work assignments in a deadline-driven work environment.
- Basic inspection skills.
- Ability to work effectively as a member of a team.
- Skill in communicating with all levels of employees, staff and external customers.
- Operates to the highest ethical and moral standards.
- Complies with company's policies and procedures.
- Adheres to quality standards set by regulations and company policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of company's business.
- Provide administrative leadership for us and provide knowledge-based expertise in related areas that can be applied to meeting the strategic goals.
- Travel as needed.
For Immediate Consideration, Apply Today! Questions? Call Grace at 714-971-0721 or Email at firstname.lastname@example.org
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