Grifols Shared Services North America, Inc Manufacturing Associate III - Bulk Fill in Emeryville, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
This manufacturing position will be responsible for production/filling of approximately 25 commercial proteins in a regulated FDA licensed/ISO certified facility. Coordinate all cross-functional activities associated with assigned production runs with downstream groups including Antigen Bulk Fill and QC testing. Perform special projects as assigned such as development and validation activities. 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 scrapping 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.
Initiate, own, and manage change control records for the department as required to support departmental projects and assigned CAPAs.
Identify and drive high level department projects and initiatives designed to improve operational capabilities either through increased efficiency or compliance.
Own and manage assigned corrective/preventative actions (CAPAs).
Participate in equipment and or process validation work.
Perform all manufacturing operations under cGMP/ISO requirements. Follow valid manufacturing procedures and documentation.
Maintain logbooks, inventory forms, revise SOPs, maintains in-process data spreadsheets, equipment, OJT and other records as required.
Completes all training documentation within a pre-defined timeframe
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.
Responsible for analyzing in-process samples generated from protein purification processes. Com-plete all required documentation for proper traceability of a production lot.
Knowledge, Skills, and Abilities:
Must have knowledge of process and equipment validation
Experience writing SOPs
Very good verbal and written communication skills
Knowledgeable in SAP and inventory control
Computer knowledge required. Experience with Word and Excel
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.
Monitor processes and products to identify opportunities for continuous improvement.
Ability to train new manufacturing associates.
BA/BS in the sciences (Biology, Chemistry, or related field)
4 to 7 years of experience in a GMP environment
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 requires a Associate's degree plus 2 years of experience, an equivalency could include 4 years of experience or a Bachelor's degree.
Ability to lift and or push 35 lbs.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home