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Form of workPosition Name: Quality Analyst I
Location: Pompano Beach, FL 33069
Duration: 7 months contract (With possible extension)
Qualifications:
Bachelor's degree in Science with 0-2 years of experience at a medical or manufacturing facility; or a minimum of a High School Diploma/GED with 3-5 years' experience in medical or manufacturing facility. Equivalent combination of education and experience is acceptable.
· Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment
· Demonstrates an attention detail; ability to stay focused on the task at hand for long periods of time
· Ability to effectively communicate; demonstrate a sense of urgency to complete production schedule on time; accepts personal responsibility for the quality and timeliness of work
· Basic computer skills i.e. Microsoft Office (Word, Excel, Outlook) · Ability to work both independently and within a team environment. · Be an advocate for a safe work environment and be responsible for my safety and the safety of others
· Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards
· Knowledge of Quality Information Systems (Trackwise, OTIS, Windchill, SAP, Lab Investigations)
Responsibilities:
Completes batch record review at final stage of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met. Issues manufacturing batch record according to the production schedule. Identify batch record issues and open non-conformances where required. Perform records coordinator activities in support of quality record retention on-site and off-site according to quality system procedures. Perform other work-related duties as assigned. Coordination with Manufacturing associates for completion/correction of DHR errors. Collaboration with QC Lab and Microbiology teams. May interact with regulators. Lead and/or participate in assigned projects. Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment. Occasional OT might be required.
Comments/Special Instructions
Quality Assurance Analyst I
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