Since 1968, ABC Laboratories has delivered expert scientific support to companies working to improve human and animal health. As a member of the ABC team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Our laboratories are modern. Our instrumentation is state of the art. And our business is thriving, creating important career opportunities. Nearly 400 people are building their careers with ABC Laboratories. See what it’s like to do what you love and love where you live! Visit www.abclabs.com to learn more about our company and our community.
The Quality Assurance Associate I provides assistance in improving ABC’s quality processes and ensure the compliance with cGMP or GLP regulations.
Job Duties and Responsibilities:
Job duties if assigned under GMP:
Job duties if assigned under GLP:
- Review and approve/reject completed client laboratory reports and manufacturing records for accuracy (of entry provided, i.e. lot numbers, calculations, etc.), traceability and completeness. Evaluate addressed deficiencies for clarity and for potential impact on compliance status. Work with production and/or laboratory personnel to correct any noted deficiencies/inconsistencies.
- Assist with implementation of quality systems and procedures (e.g. CAPA, Change Control, Training, etc.)
- Assist with internal quality audits (cGMP and DEA).
- Review and approve equipment calibrations/qualifications/validations for adherence to company procedures and federal guidelines.
- Review raw data and draft report audits – to assure raw data is an accurate reflection of the study and is reported and transcribed without error into final report. To assure study was conducted in accordance with specified regulations.
- Conduct “in progress” audits of procedures to ensure accordance with regulations.
- Protocol review to assure protocols are in accordance with specified regulations.
- Standard Operating Procedure is reviewed for accuracy and consistency.
- Final report review, which includes incorporation of any Sponsor comments and verification from sponsor of permission to finalize.
- Update Master Schedule in accordance with specified regulations.
- Performs other related duties as required and directed.
- Bachelor's degree.
- Associates degree with two years directly applicable experience.
- High School diploma and four years of directly applicable experience.
In addition to minimum requirements listed above, will assess against preferred qualifications:
- Familiarity with GLP regulations.
ABC Laboratories regrets that it is unable to sponsor employment Visas or consider individuals on time-limited Visa status for this position.