About this role
<style type="text/css"> table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_06_GPO.jpg/a5d80af4-bb13-a8cd-d567-ea1e87192f07?t=1636640424362" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">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.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif">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. </span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Responsibilities: </span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Execute the day-to-day activities of to ensure the designated program is maintained for one of the following areas:</span> <ul style="list-style-type:circle;margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Reference qualification program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Retention program (antigen/raw materials)</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Critical Reagent qualification program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Antigen stability program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Seed Stock stability program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Equipment/eSystems/calibration/maintenance programs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">LIMS</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Analytical Method Validation coordination</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">DR and CAPA program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">EH&S programs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">OE/5S/6S program</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">QC specific projects (such as eLab)</span></li> </ul> </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Perform assigned testing as required in the following areas:</span> <ul style="list-style-type:circle;margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Routine in-process, final product (antigens) testing for release of product</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Routine testing for release of Raw Material</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Seed Stock manufacturing and testing</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Equipment/eSystems (Equipment onboarding, LIMS)</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Antigen Stability, reference/reagent qualification testing</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Seedstock Stability testing</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Cleaning and or Process Validation testing</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Analytical Method Validation</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Product/Method development</span></li> </ul> </li> </ul> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;color:#262626">Assist with the planning and execution of OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Comply Site Environmental Health & Safety (EH&S) requirements</span></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Additional Responsibilities:</span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Compliance to stability and retention programs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Timely qualification of reference and critical reagents</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Maintenance of LIMS</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Timely release and stability testing for all antigen product lines</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Timely release and stability testing for all seedstocks</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Timely release testing for RMs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Investigation and closure of DRs and closure of CAPAs within the required time</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Efficiency of assigned laboratory operations.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">No safety incidents or HSE related observations.</span></li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Knowledge, Skills, and Abilities</span></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Must have substantial experience in one or more of the main areas listed:</span> <ul style="list-style-type:circle;margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits. </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing and Growth Promotion.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Bacterial and Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity and phenotype testing, DNA Plasmid isolation and restriction digest testing.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">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</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Analytical/Microbiological Method Validation testing such as Bacteriosis and Fungistasis, linearity, specificity and robustness tests in protein chemistry, microbiology or complendial test methods</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Assay trouble shooting experience in their expert area</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">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</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Stability and retention programs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Critical reagent and reference qualification programs</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">LIMS</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">QC Equipment/calibration maintenance programs</span></li> </ul> </li> </ul> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">• Strong scientific analytical skills, proficient in MS Word, MS PowerPoint and MS Excel software </span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">• Must be familiar with GMP's and Quality System Regulations (QS Regs)</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">• 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.</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">• Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines. </span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">• Must meet the two (2) mission critical competencies: 1)Customer Focus 2) Function/Technical Skills</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Education</span></strong></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 5 years or MS degree in science with 3 plus years.</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><strong><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Experience</span></strong></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">At least 5 years’ experience in a regulated GMP testing laboratory with 2 years in an independent role.</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">Equivalency</span></p> <p style="margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"><span style="font-size:11.0pt;font-family:Calibri, sans-serif;color:#262626">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. </span></p> <p style="line-height:115%;margin:0.0in;font-size:12.0pt;font-family:Cambria, serif"> </p><p><span style="font-family:arial, helvetica, sans-serif">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!</span></p> <p> </p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt;font-family:arial, helvetica, sans-serif">Third Party Agency and Recruiter Notice:</span></p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt;font-family:arial, helvetica, sans-serif">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.</span></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><span style="font-family:arial, helvetica, sans-serif"><strong><span style="font-size:11.0pt">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.</span></strong></span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters</strong></span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></span></p> <p> </p>