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Grifols Shared Services North America, Inc Manufacturing Associate II in Emeryville, California

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Summary:

This manufacturing position will be responsible for the production/filling of approximately 25 commercial proteins in a regulated FDA licensed/ISO certified facility. Refer to the associated department-specific Task List for additional requirements.

Primary responsibilities for role:

  • Responsible for the ordering of required raw materials, reagents, and starting material in preparation for assigned production runs. Also responsible for the thorough assembly, completion, and review of run specific batch record packets.

  • Perform SAP duties that include cycle counting, reservations, charges to process orders, and scrap-ping of expiring raw materials.

  • Perform specific preventative maintenance related tasks as assigned by the area manager, including column testing procedures on an annual basis and those associated with ongoing validation studies.

  • Operates complex fermentation, synthesizer, filtration and centrifugation equipment.

  • Maintain safe work environment complying with biohazard and chemical safety procedures.

  • Perform all manufacturing operations under cGMP/ISO requirements

  • Adheres to valid manufacturing procedures and documentation.

  • Maintain logbooks, inventory forms, revise SOPs, equipment, OJT forms and other records as re-quired.

  • Performs legible, clear and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in a cGMP process.

  • Responsible for analyzing in-process samples generated from protein purification processes. Com-plete all required documentation for proper traceability of a production lot.

  • Operate a variety of basic lab equipment (pH meters, balances, centrifuges, and spectrophotometers) as well as more sophisticated equipment such as computers, HPLC systems, and densitometers

Knowledge, Skills, and Abilities:

  • Must have knowledge of process and equipment validation

  • Experience following and writing SOPs

  • Very good verbal and written communication skills

  • Knowledgeable in SAP

  • Computer knowledge required. Experience with Word and Excel

  • Able to lift and push up to 35 lbs

  • Strong attention to detail, able to document work accurately, excellent organizational skills

  • Experience with preparation of reagents following manufacturing instructions

  • Experience in project management

  • Deliver quality products and services on time to all customers, internal and external

  • Must be attentive to detail and effectively manages time

  • Independent thinking and considers the overall impact of our product for internal and

External customers

Education:

  • BA/BS in the sciences (Biology, Chemistry, or related field)

Experience:

  • 2 to 4 years of experience in a GMP environment

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and /or competencies may be considered in place of the stated requirements Example: if a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor’s degree.

  • May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 204327

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