Grifols Shared Services North America, Inc Manufacturing, Associate III (Fermentation-2nd Shift) in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
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 the 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. Complete 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 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 related education 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 or experience, an equivalent could include 4 years of experience or a Bachelor’s Degree.
Ability to lift or push 35 pounds.
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.
The estimated pay scale for the Manufacturing Associate III role based in Emeryville, California is $35.28-$52.92 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and careerprogression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! “
Req ID: 499861