- 191652 - Manufacturing Coordinator, Batch Record Review
- CA-Southern California - San Diego
- San Diego
- Up to $22.00 DOE
- 10 mos
- Chipton-Ross is seeking a Manufacturing Coordinator, Batch Record Review for an opening in San Diego, CA.
Manage and maintain documents including supplier/vendor files and project associated files (e.g., batch records, testing records, validation records, and other documents as applicable). Perform batch record issuance and review. Ensure compliance to documented batch records and all associated procedures. Manage data entry of training files to permit execution of required tasks to support compliance to regulatory requirements, policies, SOPs. Meet regulatory requirements, internal KPIs and provide department metrics as needed to management.
A minimum of 1 years detailed oriented work experience in a regulated environment. Skill in reading documents written in standard English text (e.g., administrative manuals). Able to systematically arrange into groups or categories according to established criteria. Working knowledge of MS Office. MS Word skills required: templates, styles, headers, working with cross referencing figures, tables, and sections. Working knowledge of FDA, GMP, and ISO 13485 is a plus. Ability to work effectively as part of a cross functional team. Ability to relate and work well with people. Excellent organizational skills. Excellent verbal/written communication skills.
Accredited high School Diploma/GED
Monday - Friday 1st shift (8am - 5pm)
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.