Job Description: QA Associate
Position Overview: Reporting to the QA Operations Manager, the QA
Associate role has a primarily focus on document management, deviation investigation, CAPA (Corrective and Preventive Action) implementation, QA On-the-Floor support, batch record and quality control data review, and other related responsibilities.
Key Responsibilities:
1. Document Management:
· Coordinate and maintain the document control system, ensuring all documents are up-to-date and comply with quality standards.
· Review, approve, and archive controlled documents, including SOPs, batch records, and other quality-related documents.
2. Deviation Investigation:
· Conduct thorough investigations into deviations from established procedures, specifications, and quality standards.
· Collaborate with cross-functional teams to determine root causes and propose effective corrective and preventive actions.
3. CAPA Implementation:
· Lead the implementation of CAPAs, ensuring timely and effective resolution of identified issues.
· Monitor and track CAPA progress and provide regular updates to relevant stakeholders.
4. Quality Compliance:
· Assist in the preparation and conduct of internal and external quality audits.
· Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements.
5. Training and Communication:
· Provide training on quality processes and procedures to relevant personnel, including QA on-the-floor support.
· Communicate quality-related information to teams, fostering awareness and adherence to quality standards.
6. Continuous Improvement:
· Identify opportunities for process improvements within the quality assurance function.
· Participate in the development and implementation of initiatives to enhance overall quality performance.
7. Other duties as assigned.
Qualifications:
Bachelor's degree in a relevant scientific field or equivalent experience.
Minimum of 2 years of experience in quality assurance in the biotechnology or pharmaceutical industry.
Experience in document management, investigations, and CAPA processes.
Familiarity with cGMP and other relevant quality standards and regulatory requirements.
Excellent communication and organizational skills.
...seek to create the conditions for an enduring, positive peace. Driver Job Description The Bloc is at a pivotal moment in our... ...Illinois Drivers License Ability to safely drive a 15-passenger van Prompt and reliable A communicator through phone calls, text...
Jones Group Services are residential and multi-family home painter contractors. We are hiring professional Painters with five years or more of experience. You know how to cut in and know the paint terms, backroll, runs, curtains, holiday, and skipper. You will be tested...
...About the role We are looking for a Product Marketing Manager to take full responsibility for our inbound marketing strategies and product positioning including social media, landing pages, blogs, and lead generation. This person will work in partnership with...
...Police Dispatcher/Dallas (75231) ~ TLETS Required!1st Shift CornerStone Staffing has partnered with one of the largest faith-based, nonprofit health care delivery systems in the United States & I am recruiting for a 1st Shift Police Dispatcher in Dallas (7523...
...RELATIONSHIPS: This position reports directly to the shift production supervisor, and/or plant manager. PRINCIPAL OBJECTIVE OF POSITION... ..., manufactures and packages product adhering to standard operating procedures (SOP) and other regulatory requirements....