What are the responsibilities and job description for the Documentation Specialist I position at System One?
Job Title: Documentation Specialist - I
Location: Durham, NC
Hours/Schedule: Mon- Fri 8am-5pm
Type: Contract
Overview
Leading pharmaceutical company looking for an experienced Documentation Specialist. Ideal candidates should have a Bachelors degree or High School Diploma and two years of GMP Biopharma experience. Candidates should have a working knowledge of cGMP's and regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Responsibilities
Requirements
Education
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
Location: Durham, NC
Hours/Schedule: Mon- Fri 8am-5pm
Type: Contract
Overview
Leading pharmaceutical company looking for an experienced Documentation Specialist. Ideal candidates should have a Bachelors degree or High School Diploma and two years of GMP Biopharma experience. Candidates should have a working knowledge of cGMP's and regulatory requirements as they apply to the vaccine/pharmaceutical industry.
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
Requirements
Education
- Bachelor degree in a Science, Engineering, English, Business or relevant discipline OR Highschool Diploma with two years related GMP Biopharma experience
- 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
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
