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Manufacturing Production Specialist (Mid)

Company: G.A.S. Global
Location: Berkeley
Posted on: June 6, 2021

Job Description:

Location:Berkeley, CADuration: 4 MonthsJob Description:DEPARTMENT/TEAM DESCRIPTIONThe Active Pharmaceutical Ingredient (API) cell culture department manufactures a recombinant protein used as a blood clotting factor for people with bleeding disorders. The manufacturing process consists of growing mammalian cells, harvesting the protein from tissue culture fluid, and isolating the protein for further purification. The operation takes place in a Good Manufacturing Practice (GMP) clean room environment.POSITION SUMMARYThis position exists to provide on-the-floor support for the manufacture of a recombinant protein used as a blood clotting factor for people with bleeding disorders. The individual will work in a BC III (Class 100,000) gowning conditions, and perform and document tasks using cGMP documentation practices.POSITION DUTIES & RESPONSIBILITIESList the primary job duties and responsibilities using headings and then give examples of the types of activities under each heading. Clean cGMP facilityo Clean facility daily to maintain clean room environmento Formulate cleaning solutionso Perform deep cleanings as requiredo Ability to move to other departments to perform cleaning as needed. Perform departmental daily checklisto Ensure equipment such as incubators, freezers, and analytical equipment are clean and maintainedo Complete check list items to keep lab Demonstrate good record keeping practices and follow data integrity ruleso Make electronic logbook entries in Technical Shift Book (TSB)o Document tasks performed and training contemporaneously Manually clean equipmento Follow SOP instructions to clean various pieces of small equipmento Don appropriate PPE for task Operate filter integrity testero Test various pieces of equipment to ensure integrityo Maintain passwords for equipment and document tasks performed Operate Autoclaveo Clean and maintain autoclaveo Run various autoclave cycles dependent on equipmento Document activity on Batch Production Record (BPR)o Verify cycle is acceptable by checking critical parametersREQUIREMENTS/PREFERENCESEducation Requirement(s): At least two-years College science courses (e.g. biology, chemistry, biochemistry, or microbiology), or a certificate from an accredited bio-technology academySkill & Competency Requirements: (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.) Must be able to work nights, weekends, holidays and overtime as required; Must meet Occupational Demands/Physical Requirement checklist; (Ability to lift up to 50 lbs. and push/pull up to 400 lbs. with assistance) Must not have unusual sensitivity to typical lab chemicals or gloves (i.e. sanitizing agents), use required chemicals and wear protective clothing (PPE) and gowning as required. Must be able to work under BC III (Class 100,000) gowning conditionso Individual must be gowned for up to 5 hours at a timeo All task performed will be in BC III (Class 100,000) gowning conditions Must possess computer skills, including: the ability to learn software applications such as the learning management system (LMS), e-mail (Outlook), MS Excel, etc;o Write and respond to emailso Gain access to various electronic platforms for training and documentation of tasks Must be able to read, write, speak, and comprehend English in order to understand written and verbal instructions,o Read Standard Operating Procedures (SOPs)o Receive verbal, written, electronic trainingo Document learning or tasks performed on applicable formsPreferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.) Relevant bio-tech industry experience in Cell Culture. Knowledge of Cell Culture, aseptic technique, cGMP documentation. Basic knowledge of protein chemistry, operation of analytical equipment such as filter integrity testers, pH meters, and Familiarity with cGMPs and applicable agency regulations.

Keywords: G.A.S. Global, Berkeley , Manufacturing Production Specialist (Mid), Other , Berkeley, California

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