- Entry level
- No Education
- Salary to negotiate
Please note the shift for this position is Monday- Friday 1:00 PM - 10:00 PM
Head of Product Analytical Chemistry QC Operations
Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines.
Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receive appropriate knowledge and skill development and growth opportunities.
Set objectives and tasks for staff.
Regularly review staff progress in meeting objectives.
Recommend improvements to Quality operational policies, plans and procedures.
Supervise routine activities and complex issues.
Ensure activities are completed on time and issues resolved within budget.
Make recommendations to department budget.
Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
Participate in continuous improvement initiatives for Genentech Quality Systems.
Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
Be accountable for behaviors described in Genentech’s Core, Common and Critical Competencies.
Follow proper safety precautions and laboratory technique in the use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
Meets scheduled performance of 95% on time.
Perform any other tasks as requested by Senior Management to support Quality oversight activities.
Provide technical and compliance guidance on test methods.
Review, evaluate and approve test data against established criteria.
Assist in the resolution of Out of Specification (OOS), complaints, discrepancies and CAPA (corrective actions preventive actions).
Review, provide input, and approve technical / investigation reports.
Recommend improvements to identified systems and procedural gaps, and implement improvements.
Guide and coach Quality Control staff in the application of cGMP throughout operations.
Receive and provide training.
Collaborate with Quality Control Management and Staff to support complex and/or multi-site projects.
Participate in internal and external audits and regulatory inspections.
Provide input and help author protocols and reports within specified Quality Control discipline.
Review and approve proposed changes to systems, test procedures, test methods, procedures and submissions to regulatory agencies.
Supervise testing for validation and qualification studies.
Education and Experience
B.A. or B.S. degree (preferably in Life Science) and 3-5 years relevant experience in the pharmaceutical or biopharmaceutical industry, including two or more years of supervisory experience, or an equivalent combination of education and experience
Sound knowledge of cGMPs or equivalent regulations
Ability to interpret and relate Quality standards for implementation and review
Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
Ability to communicate clearly and professionally both in writing and verbally
Flexibility in problem solving, providing direction and work hours to meet business objectives
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.