QC Chemistry Team Lead - 3rd Shift 8/9/2016
Gilead Sciences, Inc
San Dimas, CA
JOB DESCRIPTIONAPPLY SPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The QC Team Lead will be Responsible for the following:
Lead a team of 3 5 people on the second shift (Wednesday Saturday 10pm 8am)
Ensure you spend at least two hours per day on the laboratory floor with the analysts.
Oversee analyst training.
Hold analysts accountable to department performance initiatives. Hold regular 1:1 s with all direct reports.
Schedule Raw Material laboratory testing to meet turnaround time metrics. Issue Analytical Reports and Certificate of Analysis s.
Own CAPAs that pertain to your area. Review non-tests and issue quarterly non-test report. Report events to QC management.
Attend cross departmental meetings as necessary. Maintain safe working conditions.
Ensure analysts have all the supplies necessary to perform testing. Run MDI board and meetings.
Write and Implement SOPs, Methods, Protocols and Reports.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Leads assigned group of staff in the QC department.
Acts as advisor and technical resource to more junior staff.
Supervises QC personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
Oversees the daily activities of team, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed.
Responsible for developing technical solutions for semi routine to moderately complex projects and issues related to the QC Chemistry department.
Proposes, implements, and qualifies current and new pharmacopoeia methods to improve processes and/or ensure compliance with GMP s and other regulatory requirements.
Provides QC Chemistry technical expertise and counsel.
Develops cleaning methods.
Writes and executes protocols and reports.
Reviews data and results of testing to ensure compliance to appropriate specifications and protocols. Troubleshoots instrumentation and test methods.
Evaluates equipment for purchase and performs installations and qualifications of the new instruments. Performs method transfers to/from other organizations.
May lead or coordinate QC and cross-functional projects.
KNOWLEDGE, EXPERIENCE AND SKILLS
6+ years of relevant experience and a BS or BA.
4+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.
Full working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
Project Management and prioritization skills.
Audit and Investigation Skills, Report Writing Skills.
Strong verbal, technical writing and interpersonal skills are required.
Proficiency in Microsoft Office applications.
Advanced excel skills for Metric reporting.
Proficient in quality control systems, methods and procedures for routine and non-routine analysis of raw materials, intermediates and finished product samples e.g. solid oral dosage, packaging component testing, raw material and sterile product testing etc
Clear, concise verbal and written communication
Ability to troubleshoot various laboratory instruments
Ability to persevere and stick with a difficult or tedious task.
Quick and flexible to changing priorities
Trustworthy and fair; engender trust from both your employees and colleagues
Have a passion for excellence and drive to excellence in the Quality Control Laboratory
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 firstname.lastname@example.org for assistance.
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