Job Location : Durham,NC, USA
Job Title: Documentation Specialist
Duration: 6 Month Contract
Location: Onsite - 100 Rodolphe Street, Bldg. 1300, Durham, NC 27712
Pay Range; $26/hr- $29.25/hr.
About the role:
Backlogged documentation.
Elogs, RT reports, Electronic batch record operations.
Reviewing records, flag (create comment), identifying records need improvements.
Quality reviews after.
Needs to also keep up w/current documentation MES, GLIMS, SAP, Veeva Vault heavily preferred.
Qualifications:
Education
Required
Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Critical thinking and problem-solving abilities
Working knowledge of cGMPs and of regulatory requirements as they apply to?the vaccine/pharmaceutical industry
Working knowledge of documentation administration including the writing, review, and approval of documentation in a GMP industry
Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray
Responsibilities:
Provide documentation support for vaccine production activities
Review batch record, logbooks and electronic logbooks for errors and partner with Production, Quality and other personnel to correct such errors and provide clarification as needed
Support process documentation changes and improvements which includes updates to batch records and standard operating procedures (SOPs)
Effectively maintain and use metrics for the manufacturing shop floor execution documentation program
Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate
Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams
Documentation Specialist will serve on the Manufacturing Support Team working with shop floor production personnel and interfacing with Technical Support and Quality Operations and must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.
The position requires great attention to detail, a command of good documentation practices (GDP) and the ability to design and strengthen documentation that satisfies Quality requirements.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.