Supervisor, Quality Control
United States - New Jersey - Morris Plains
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Essential Duties and Job Functions:
Required Education and Experience:
- Supervises daily activities of QC Environmental Monitoring and Testing Analysts and assures that job activity deadlines are met on a timely basis.
- Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development.
- Schedule and assign/prioritize laboratory activities to ensure alignment with organizational goals. This includes coordinating the weekly/daily schedules and resources within team and between other departments to meet production, compliance, and department objectives.
- Provides technical expertise in microbiology testing area, creates and approve protocols and reports for, and participates in, the validation of simple or complex tests, the transfer of such tests, or qualification of equipment
- Performs critical records documentation and reviews and participates in documentation preparation and assists with regulatory audit review. Reviews and approves QC testing and environmental monitoring data, escalates issues to management as needed.
- Notifies laboratory management when unusual results, trends, or data deviations occur. Composes investigations as it pertains to microbiological testing and results.
- Proficient in method development, validation, and verification for new and existing microbiological tests and equipment.
- Researches and recommends new technologies.
- Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, and technical reports as needed.
- Issues deviations, Phase I/II laboratory investigations, corrective actions, change controls, and monitors effectiveness checks.
- Participates in internal/external audits including self-inspections.
- Represents department on project and cross-functional teams and committees when needed.
- Escalates issues to manager for resolution, as deemed necessary.
- Develop team members by continually growing employees through challenging experiences, identify areas for development, actively coach, and provide development and learning opportunities.
- Bachelor's degree in microbiology, biology, or other relevant scientific discipline and 6+ years of related pharmaceutical lab experience; or equivalent combination of education and experience.
- 1+ years of direct supervisory experience; or equivalent combination of education and experience.
- Prior experience working in a cGMP/GLP environment required.
- Must possess proven understanding of SOPs, cGMP and GLPs guidelines and regulations.
- Experience in Microbiological Testing Methods Required (Bioburden, Endotoxin, and growth promotion).
- Expertise with performing laboratory investigations, change controls, and associated CAPAs.
- Thorough knowledge of all areas of testing in a pharmaceutical Microbiology laboratory.
- Good knowledge of cGMPs, GLP, FDA guidelines, ICH Guidelines, USP and EP; Microbiology techniques and instrumentation; project management; OOS/OOL investigations; and risk assessments.
- Must possess excellent communication (oral and written), organizational, and interpersonal skills.
- Detail oriented with strong aseptic techniques and documentation skills.
- Must have prior method development/validation experience with environmental monitoring, bioburden and bacterial endotoxin for analysis of raw materials and in-process.
- Must be proficient with MS Office applications.
- Microbiological method development, transfer, and validation experience is highly preferred.
- Experience with Kinetic Endotoxin System and Vitek ID System is a plus.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com
For more information about equal employment opportunity protections, please view the EEO is the Law'
poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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