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Quality Analyst I - (Biotech/Biomedical)

3bjdnwaxpar6fqztzu6mhx5d0xyrn100fc3iv75z44r9e0v7xa2dz7r3fyz3ex0n · 30+ days ago

Pompano Beach, FL, US

$44k+
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Full-time

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JOB DESCRIPTION:
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.

Qualifications:
Bachelors 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)

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. •

Last updated on Nov 29, 2023

About the company

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