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Grifols Shared Services North America, Inc Team Lead, Manufacturing 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.

Summary:

The Team Lead role will lead manufacturing run activities including all applicable pre-production and post-production tasks required to support the full process. This position will also provide leadership and guidance to other manufacturing associates assigned to the applicable run. Refer to the associated department-specific Task List for additional requirements.

Primary Responsibilities for the role:

● Guide and lead the work of department associates executing daily operations.

● Act as a point of contact for the production of an assigned antigen run from start to finish.

● Assign production support activities to other associates in accordance with the schedule.

● Ensure that all production operations are conducted in full compliance with Grifols policies, regulatory (GMP, FDA, ISO) and safety requirements.

● Coordinate pre-production checks and activities as required.

● Troubleshoot and resolve applicable technical issues encountered in the process

● Coordinate and execute applicable analytical testing activities.

● Assist with batch record review and corrections as required .

● Review, initiate, and approve change requests for the department.

● Initiate production related deviations in the associated quality system

● Manage assigned investigations as required including the implementation of corrective actions.

● Own and manage assigned corrective/preventative (CAPA) actions in the associated quality system.

● Coaching and mentoring whenever necessary, foster positive, result-driven teamwork environment.

● Can perform supervisory activities as needed or as assigned.

Knowledge, Skills, and Responsibilities:

• Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements.

• Computer skills are required (Word, Excel, Outlook). SAP, ATLAS, and Track Wise based system knowledge a plus.

• Strong technical knowledge in commercial Purification and separation techniques.

• Strong troubleshooting abilities including process monitoring to identify opportunities for continuous improvement.

• Strong interpersonal and cross functional team building skills

• Must have experience supporting and/or leading deviation investigations.

• Excellent communication skills, organizational skills, writing and problem-solving skills required.

• Must be able to work independently and make critical decisions.

• Must establish proper priorities and manage time and available resources.

• Must be able to establish and maintain effective working relationships with customers and co-workers.

• Understand the operation of all equipment associated with the process being supervised.

• Understand GMP, FDA and ISO regulatory requirements.

• 5S, Lean manufacturing knowledge a plus.

• Strong organization and time management skills, with the ability to prioritize and get activities completed on-time.

• Established troubleshooting abilities including process monitoring.

• Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements.

Education:

Minimum requirements: BS/BA in one of the biological or physical sciences.

Experience:

Minimum of 6 years’ experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment.

Equivalency:

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.

Occupational Demands:

Ability to lift or push 35 pounds.

More about us, benefits we provide you

  • Salary in line with the market as well as an annual bonus target

  • Free parking

  • Professional development opportunities (training, career development)

  • Gym pass, Employees perks program

  • 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)

  • Health insurance: Medical, Dental, Vision

  • Travel accident insurance, Life and AD and D Insurance

  • Short- & Long-Term Disability Insurance

  • Health Savings Account, Flexible Spending Account

  • Critical Illness, Accident, Hospital Indemnity coverages

  • Adoption Assistance

  • Employee assistance plan

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 Team Lead, Manufacturing role based in Emeryville, California is $38 - $57 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 career progression. 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!

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

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Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 500587

Type: Regular Full-Time

Job Category: Manufacturing

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