Document Imaging Supervisor oversees personnel responsible for operating document imaging equipment for use in the creation of images or text. Document Imaging Supervisor, a level I supervisor is considered a working supervisor with little authority for personnel actions. Being a Document Imaging Supervisor may require a bachelor's degree in area of specialty. Typically reports to a manager or head of a unit/department. Working team member that may validate or coordinate the work of others on a support team. Suggests improvements to process, is a knowledge resource for other team members. Has no authority for staff actions. Generally has a minimum of 2 years experience as an individual contributor. Thorough knowledge of the team processes. (Copyright 2024 Salary.com)
Seeking 1 Document Control Specialist
Onsite in Stratford, CT
Description:
Pre-production preparation, review, and approval of batch records for various cGMP OTC, medical device, and pharmaceutical products
Post-production batch record review and approval
Review production data and draft COA and COC from this data using approved templates
Trend data collected from batch records and update periodically
Diagnose and propose areas of growth within current QMS
Print, scan, file, and archive batch records and other quality documents
Support the Director of Quality with quality-related activities
Work smoothly within a devoted team
Skills:
qa/qc, batch record review, gmp, fda, pharmaceutical, medical device, coa, cmp, capa
Additional Skills & Qualifications:
Bachelor's degree in science related field (MS preferred)
2 years in like or similar function in pharmaceutical or medical device industry cgmp
Strong communications skills and proficiency with the English language, specifically scientific, pharmaceutical, and medical device nomenclature
Experience working in a cGMP environment
Experience working with and familiarity with cGMP quality documentation such as batch records, NCRs, CAPAs, SOPs, DCRs, COAs, COCs, etc.,
Knowledge of industry guidance and regulations from FDA, ICH, ISO, etc.,
Experience with data review, compilation, and trending
Strong editing skills
Strong proficiency with Microsoft product suite
Experience Level:
Intermediate Level
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