Title: QA Document Control Specialist

Location: Princeton, NJ

Schedule: Monday – Friday (8am-430pm)

Type: Temp to Hire

Start date: ASAP

Responsibilities:

• Oversees the revision, issuance and tracking of controlled documents used to support of clinical and commercial GMP manufacture of cell therapy products
• Create and revise company standard operating procedures
• Assist in review of cGMP-controlled documents as necessary, including assessing where new controlled documents fit within the QMS.
• Participates in resolving deviations associated with the Document Management System
• Handles non-routine situations for review and approval by senior staff
• Provide recommendations that consistently result in favorable project results and client satisfaction.
• May work directly with Clients, the QA department and other company departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
• Ensures basic grammatical accuracy and completeness when revising documents.
• Filing, tracking and archival of GMP documentation.
• Conducts internal audits of company systems and documents where needed to ensure compliance to applicable company Policies and SOPs.
• Provides reports to Upper Management and Project Management regarding document status
• Assure that any data tracking systems are kept current and are operating as efficiently as possible.
• Assist in the coordination of document management system.
• Support regulatory (FDA, EMA) and client audits/inspections of company.
• Compile and provide applicable metrics for periodic Management review
• Processes, distributes, and maintains controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using a document control system.
• Issuance of Batch Production Records

Requirements:

• High School Diploma and 4 yrs. exp. with GMPs in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.
• BS degree in Science field or Engineering with 6 month to 2 yrs. exp. in Biopharma manufacturing
• Microsoft Word and Microsoft Excel experience
• Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.