This temporary Manufacturing Operations Specialist supports production activities by preparing required production-related documents. This role collaborates with the manufacturing team and with cross-functional departments.
Essential Duties & Responsibilities
· Manage documents, order materials to support production process.
· Enter batch data in Operations databases and ensure data integrity.
· Manage materials ordering work order processes.
· Assist with material verification and transport into manufacturing suite.
· Enter data into Trackwise for events and change controls.
· 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.
· 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 documentation 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
o (1) knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, CIP/SIP systems, aseptic filling, and
o (2) knowledge of basic chemical and biological safety procedures.
· 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 overgarment and head cover.
· May be required to balance occasionally, when gowning for clean rooms.
May be required to stand occasionally, when inside clean rooms