Accountability Clerk
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The Accountability Clerk is responsible for the reviews of production batch records and work plans. Performs clerical and administrative duties to support the department and other duties as assigned.
Job Responsibilities: Performs the production review of manufacturing and packaging batch records and work plans. Tracks batch record and work plan documentation errors. Initiates and/or reviews NOEs as needed. Presents batch record error information to operators at monthly production meetings. Acts as backup for writing the finishing work plans as needed. Acts as backup for completing statistical process control workbooks as needed. Acts as backup for data entry of on-line coat weights as needed. Performs special projects and assignments as needed. Performs miscellaneous duties as assigned by the Director or Vice President of Production Works as a member of a team to achieve all outcomes; Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and All other relevant duties as assigned.
Education o College degree (A.A./A.S., B.A./B.S). or three to five years of related experience and/or training.
Knowledge Skills and Abilities o Ability to read English and interpret documents and batch records. o Ability to write and word process English. o Ability to speak English effectively and communicate with all company employees. o Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals. o Ability to round decimals, compute ratio, percent and interpret data graphically. o Must possess basic Microsoft excel, word and access software knowledge. o Knowledge of FDA, cGMPs, and SOPs related to job requirements. Experience o Previous pharmaceutical manufacturing, packaging or batch record review experience required.
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