Title: Manufacturing Operations Specialist
Location: Los Angeles, CA
Duration: 6 months(possible extension)
The temporary Manufacturing Operations Specialist supports production activities by revising and preparing required production-related documents. This role collaborates with the manufacturing team and with cross-functional departments.
Essential Duties & Responsibilities:
- Author, revise, or prepare documents (SOPs, BPR, Forms, Job Aides) to assist in the implementation of measures that will minimize the number of exceptions occurring in the production process.
- Enter data in various Operations databases and ensure data integrity. Update SOP manual binders on the production floor, order batch production records, review batch production forms and logs, maintain and archive production records in coordination with the Document Management Dept.
- As requested, represent Manufacturing as a participant in special project teams.
- Qualifications Bachelor’s degree with preferred experience to include 1+ years of experience in a CGMP manufacturing environment.
- Scientific or Engineering degree is preferred.
- Strong computer skills including advanced Word and basic Excel, SharePoint, and exposure to document management systems.
- Demonstrated experience writing documents/reports.
- Demonstrated ability to organize work priorities Strong attention to detail Good interpersonal skills and ability to work effectively and efficiently in a team environment and across departments. Preferred experience includes
(1) knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, CIP/SIP systems, aseptic filling
(2) knowledge of basic chemical and biological safety procedures.
Working Environment Typical office environment including regular use of computer. On occasion, the position involves entry into the Production area, requiring the use of Personal Protective Equipment (PPE). No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in areas requiring PPE. Pace may be fast and job completion demands may be high.
Physical Demand:
The overall physical exertion of this position is sedentary work. Must be able to perform gowning operations, including donning over garment and head cover. May be required to balance occasionally, when gowning for clean rooms. May be required to stand occasionally, when inside clean rooms.