Quality Assurance Associate
- Quality Assurance Monitoring: Review and approve routine inspections and quality checks of raw materials, in-process samples, and finished products to ensure compliance with regulatory requirements and internal quality standards.
- Documentation and Reporting: Maintain accurate records of company activities, including test results, deviations, and corrective actions. Prepare and review quality documentation, including SOPs, batch records, and reports.
- Quality Management System: Maintain eQMS system including SOPs, Change Control, Deviation, Reports, and Protocols.
- Supplier Evaluation Process: Support the maintenance and introduction of suppliers including Approved Supplier List (ASL) and supplier audits.
- Compliance: Assist in the development and implementation of quality assurance procedures and guidelines. Ensure that manufacturing processes adhere to Good Manufacturing Practices (GMP) and other relevant regulations.
- Problem Solving: Investigate and resolve quality issues, including deviations and non-conformances. Collaborate with cross-functional teams to identify root causes and implement corrective and preventive actions.
- Audits and Inspections: Support internal and external audits by preparing necessary documentation and facilitating inspection processes. Assist in addressing audit findings and implementing recommendations.
- Training: Participate in training sessions and workshops to stay updated on industry regulations and best practices. Support training efforts for other team members on quality-related topics.
- Maintain the cGMP training program for the company through eQMS system.
- Provide support to the Quality Director in the development and implementation of strategic Quality initiatives.
- Act as backup to the Quality Director for meetings and oversight of the Quality department, as needed.
- Provide support for Complaint and Adverse Event resolution.
- Provide leadership and ownership in exposing and eliminating problems in areas of responsibility. Play an active role in process improvement and problem solving.
- Ensure proper communication of company policies such as safety, breaks, clean room protocol, etc.
- Other duties as required.
- Minimum Bachelor's Degree required.
- 2-4 years of experience in a quality role within the pharmaceutical or related industry is preferred.
- Must have computer skills and familiarity with all Microsoft Office programs (i.e. Word, Excel, etc.).
- Strong understanding of GMP, FDA regulations, and other relevant industry standards.
- Proficiency in quality techniques and documentation practices.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational skills.
- Effective communication skills and the ability to work collaboratively in a team environment.
- Stand, walk, bend, squat, twist, reach or otherwise move frequently
- Occasional repetitive motion and grasping
- Occasional climbing to reach areas on machines or racks
- Lift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequently
- Typically sits, grasps items or performs keyboarding for occasional operation of a computer
- Exposure to typical machine shop physical hazards which may require respiratory protection
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