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.Job Summary:The QC Chemistry Supervisor is responsible for the daily activity of a GMP compliant lab which performs various chemical and biochemical assays on protein-based therapeutics and raw materials to support the release of intermediates and finished products. The supervisor is responsible for delegating daily tasks and ensuring that all tests are executed appropriately and reviewed in a timely manner. The supervisor provides hands-on training of laboratory analysts to enhance work knowledge and productivity.Essential Job Duties:
Conduct validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes.
Develop qualification and validation protocols for manufacturing systems and equipment such as ultra-filtration units, chromatography columns, automation controls, utilities, clean rooms, temperature controlled areas, pasteurizers, lyopholizers, etc.
Execute approved studies and protocols to gather data.
Analyze the resulting data and develop the final validation report.
Responsible for completion of studies within validation project time lines. Assists in the development of the time lines and communicates project updates within the validation department.
Investigate and document all validation related deviations and determine assignable cause.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.
Job Requirements:
Bachelor’s degree in Chemistry, Biochemistry, Biology or closely related scientific discipline is required.
Minimum of 4 years of related chemistry experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is required.
Requires an in depth understanding of analytical methodologies and protein biochemistry (e.g. IC, HPLC, GC, etc.).
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Prior supervisory or leadership experience is highly preferred.
Demonstrated ability to inspire high performance in others and align team members around shared goals.
Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
Demonstrated project management skills.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Specific experience with LIMS (Laboratory Information Management System) is preferred.
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
The estimated pay scale for the Supervisor, Chemical Control role based in Los Angeles, CA, is $26.22-$28.00/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 accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.Learn more about Grifols (https://www.grifols.com/en/what-we-do)Req ID: 518587Type: Regular Full-TimeJob Category: Quality