QC Lead

The lead will assist the Supervisor or QC Manager with the day-to-day operation of one of the programs or specific projects within the Grifols Diagnostic Solutions Quality Control Laboratories which consist of: Method Validation, Antigen Release and Stability, QC Raw Materials (QCRM), QC Microbial (including seedstock) and QC Equipment/eSystems programs. The lead will independently perform the daily activities required to maintain the assigned program, testing or assigned project.

Responsibilities:

• Execute the day-to-day activities of to ensure the designated program is maintained for one of the following areas:
  
  
  
  • Reference qualification program
  
  
  • Retention program (antigen/raw materials)
  
  
  • Critical Reagent qualification program
  
  
  • Antigen stability program
  
  
  • Seed Stock stability program
  
  
  • Equipment/eSystems/calibration/maintenance programs
  
  
  • LIMS
  
  
  • Analytical Method Validation coordination
  
  
  • DR and CAPA program
  
  
  • EH&S programs
  
  
  • OE/5S/6S program
  
  
  • QC specific projects (such as eLab)
  
  
  
  


• Perform assigned testing as required in the following areas:
  
  
  
  • Routine in-process, final product (antigens) testing for release of product
  
  
  • Routine testing for release of Raw Material
  
  
  • Seed Stock manufacturing and testing
  
  
  • Equipment/eSystems (Equipment onboarding, LIMS)
  
  
  • Antigen Stability, reference/reagent qualification testing
  
  
  • Seedstock Stability testing
  
  
  • Cleaning and or Process Validation testing
  
  
  • Analytical Method Validation
  
  
  • Product/Method development
  
  
  
  

• Assist with the planning and execution of OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work


• Comply Site Environmental Health & Safety (EH&S) requirements

Additional Responsibilities:

• Compliance to stability and retention programs


• Timely qualification of reference and critical reagents


• Maintenance of LIMS


• Timely release and stability testing for all antigen product lines


• Timely release and stability testing for all seedstocks


• Timely release testing for RMs


• Investigation and closure of DRs and closure of CAPAs within the required time


• Efficiency of assigned laboratory operations.


• No safety incidents or HSE related observations.

Knowledge, Skills, and Abilities

• Must have substantial experience in one or more of the main areas listed:
  
  
  
  • Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits.
  
  
  • Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.
  
  
  • Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.
  
  
  • Environmental/Utility/facility Monitoring testing such as Sampling of and testing of manufacturing water by membrane filtration, viable and non-viable particulate testing of facilities and utilities, viable (surface) monitoring of manufacturing facilities, personnel and biological hoods, moisture and oil content testing of compressed gases
  
  
  • Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods
  
  
  • Assay trouble shooting experience in their expert area
  
  
  • Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color and appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
  
  
  • Stability and retention programs
  
  
  • Critical reagent and reference qualification programs
  
  
  • LIMS
  
  
  • QC Equipment/calibration maintenance programs
  
  
  
  

• Strong scientific analytical skills, proficient in MS Word, MS PowerPoint  and MS Excel software

• Must be familiar with GMP's and Quality System Regulations (QS Regs)

• Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.

• Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.

• Must meet the two (2) mission critical competencies: 1)Customer Focus 2) Function/Technical Skills

Education

Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 5 years or MS degree in science with 3 plus years.

Experience

At least 5 years’ experience in a regulated GMP testing laboratory with 2 years in an independent role.

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.

The estimated pay scale for QC Lead role based in Emeryville, California, is $99,155 to $123,943.75 annually. 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.

Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters

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