Documentation Specialist I Position Available In Durham, North Carolina
Tallo's Job Summary: Leading pharmaceutical company in Durham, NC is seeking an experienced Documentation Specialist I. Candidates need a Bachelor's degree or High School Diploma with two years of GMP Biopharma experience. Responsibilities include providing documentation support for vaccine production activities and supporting process documentation changes. Competitive benefits package offered.
Job Description
Documentation Specialist
I 3.6 3.6
out of 5 stars
Durham, NC 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 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 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 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
