Durham, NC, 27722, USA
1 day ago
Documentation Specialist - I (Assistant)
Our client, one of the largest Pharmaceutical companies in USA is looking for a Documentation Specialist - I (Assistant) to work at Durham, NC Job title: Documentation Specialist - I (Assistant) Location: Durham, NC 27712 Duration: 6 months contract Pay range: $20 - $25 per hour **Must haves:** 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 **Qualifications:** **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 **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. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent. 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.
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