Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The QC Specialist 2 acts as a Lead in their workcell and has a strong understanding of products (QC testing, specifications, QC processes, assay knowledge) within the assigned workcell. They have a solid understanding of SQC Trend analysis, Enterprise Resource Planning, and GMP/GLP requirements. The QC Specialist 2 has intermediate technical writing skills, with basic knowledge of experimental design. This role may act as Lead for their workcell, scheduling activities, communicating with Production Planners.

Primary responsibilities for role

• Performs routine testing as needed.
• May lead one or more analysts.
• Designs and executes experiments to troubleshoot non-conformances.
• Generates, performs and documents laboratory investigations and non-conformances. Uses standard root cause determination methods.
• Review/analyze data with respect to specifications, validity criteria, alert limits.
• Oversees lab maintenance duties. Ensures labs are within a state of compliance. Performs periodic lab audits.
• Initiates and leads document change control activities. Able to create/revise QC documents (procedures and specification documents)
• Coordinates testing within a work-cell. Communicates closely with planners/QA on product release priorities and issues.
• Create and approve CofAs.
• Works closely with QC Scientist on method transfer (NPD).
• Acts as the lead trainer for QC work-cell.
• Performs and documents investigations using standard root cause determination methods
• Assists in software & hardware upgrades including executing test protocols.
• Initiates clear and concise non-conformances. Performs and documents low severity investigations.
• Monitors trend dashboards for work-cell product lines.

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.

Additional Responsibilities:

Technical Writing Skills, Continuous improvement methodology, Additional responsibilities as assigned

Knowledge, Skills, and Abilities:

• Working knowledge of Enterprise Resource Planning (ERP), QSR, GMP/GLP requirements.
• Working knowledge of industry/regulatory standards.
  
  
• Intermediate computer skills

Education B.A. or B.S

Experience 6 years

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 requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

The estimated pay scale for Quality Control Specialist 2 role based in Califo rnia, is $91,225.00 to $115,000.00 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and 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!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

California Personnel Privacy Policy and Notice at Collection

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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