Documentation Specialist I

Primary Talent Partners has a 6 month contract opening for a Documentation Specialist to join a multinational pharmaceutical company for an onsite position operating out of Durham, NC.

Pay: $25.00/hr - $29.00/hr
Contract: 6 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship

Summary:
The 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.

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

Required Qualifications:

• Bachelor degree in a Science, Engineering, English, Business or relevant discipline OR Highschool Diploma with two years related GMP Biopharma experience 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
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

#PTPJobs