Job Description Job Description
Description:
Monday - Friday 8:00 Am - 4:00 Pm 5x onsite
Job Summary:
- QC Specialist is expected to support planning, managing, and executing projects related to the product portfolio for Vacaville Quality Control.
- These projects include analytical transfers, control system updates, regulatory filings and other activities associated with the life-cycle of a product.
- In addition, the individual may be required to partner with customers across the site and with other Client sites in order to achieve the objectives of the project.
Where possible, this role also requires the individual to develop and improve processes and procedures not only associated with their work but also related to other Quality Control activities at the site. - This position resides within Vacaville Quality Control organization and is charged with aiding the organization in accomplishing its goals and objectives, especially related to new product and/or technology transfers.
Duties:
- Project Management Assist with projects and simple to complex technical activities associated with method improvements, method transfers, and possibly lab related activities
- Work to meet schedules, timelines, deadlines.
- Support staff on project teams.
- Work with internal departments, collaborators and partners concerning projects and commitments. Support coordination with customers to support multi-site operational activities.
- Assure and apply GMP throughout operations.
- Participate in group and project teamwork activities; project and process improvements.
- Meets scheduled performance of 95% on time.
- Assist in execution of projects such as method transfers, and method validations.
- Support simple to complex technical activities associated with products, control systems, health authority filings.
- Support methods monitoring and reference material replenishment and testing. Identify discrepancies, as applicable.
Required skills and competencies:
- BS/BA degree and minimum 2-3 years of experience in commercial quality control, preferred. Education experience preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
- Knowledge of GMP quality control pharmaceutical systems strongly desired.
- Strong skills in detailed planning with cross-functional teams
- Ability to negotiate, influence, and make decisions in order to meet local, network, and global objectives and initiatives.
- Strong verbal and written communication skills, ability to organize and present information both formally and informally.
- Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in multiple analytical and/or biological test procedures.
- Routinely exercises sound judgment, reasoning and problem solving.
- Capable of working with moderate independence or under moderate supervision and planning priorities and supporting potentially multiple projects and teams.
