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Documentation Specialist

Company: Spectraforce Technologies Inc
Location: Fremont
Posted on: January 15, 2022

Job Description:

Job Title: Documentation Specialist Location: Fremont CA 94555 Duration:12 Months Job Description: Duties: This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met. Independently executes (paper/electronic) batch record review - Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory. Skills: Demonstrated proficiency in MS Office programs and associated computer programs. Technical knowledge of manufacturing systems, methods and procedures. Must have excellent written and verbal communication skills. Awareness and understanding of Manufacturing processes Education: Requires a Bachelors degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment. --- In lieu of a Bachelor's degree, will consider an Associate's degree plus 4 years of professional experience in a GMP environment environment or clean room assembly environment. Note: This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned. Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law. Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require a reasonable accommodation. For the full list of our open positions, please check Job Requirements:Duties: - - - - - - - - - - - - - - This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met. -Independently executes (paper/electronic) batch record review- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.

Keywords: Spectraforce Technologies Inc, Fremont , Documentation Specialist, Other , Fremont, California

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