Essential Functions: Provides hands-on guidance to Manufacturing Technicians. Conducts Technicians’ performance evaluations and one-to one meetings Assigns daily job responsibilities. Expedites production scheduling through communication with QA/QC and Inventory Control personnel. Participates in production processes, including cleaning and set-up. Complies with all established SOPs in performance of job. Adheres consistently to GMPs. Investigates and reports on variance or deviations from standard procedures. Has daily contact with Compliance, Inventory Control and Maintenance to ensure equipment and materials are ready and available for use. Physical Requirements for the role: Must be able to work on a rotational shift schedule alternating between day shift and grave shift Must be able to work weekends Must be able to work holidays Must be able to operate and qualify for respirator usage Must be able to see and distinguish all colors and shades Must be able to stand for a continuous 4 hours Must be able to change into Gilead gowns and work attire as required for the task Occasionally lift 50 lbs Routinely lift 25 lbs Knowledge, Experience, and Skills: 6+ years of relevant experience and a BS or BA. 4+ years of relevant experience and a MS. Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred. Proficient knowledge of Good Manufacturing Practices (GMPs) Audit and Investigation Skills, Report Writing Skills. Strong verbal, technical writing and interpersonal skills are required. Proficiency in Microsoft Office applications. Must possess a strong knowledge of the FDA/IMB and cGMP standards as well as regulatory guidance documents.
All City Management Services Azusa, CA
All City Management Services Glendora, CA
City of Azusa Azusa, CA
Pet Service Solutions Pomona, CA
Brookdale Senior Living San Dimas, CA