QC Specialist II

Vacaville, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.

Job Title: QC Specialist II

Location: Vacaville CA 95688

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: Monday to Friday from 08:00 AM to 04:00 PM

Summary:

Under moderate supervision the QC Specialist supports 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 product life-cycle activities.
The individual partners with customers across the site and with other locations to meet project objectives.
Additionally they contribute to developing and improving processes and procedures related to Quality Control activities.
This position plays a critical role in new product and/or technology transfers within the Vacaville Quality Control organization.

Responsibilities:

Assist in managing projects and technical activities associated with method improvements method transfers and lab-related activities.
Support project teams to meet schedules timelines and deadlines.
Collaborate with internal departments external partners and customers to support multi-site operational activities.
Ensure GMP compliance throughout operations.
Participate in project teamwork process improvements and group initiatives.
Achieve scheduled performance targets (e.g. 95% on-time delivery).
Assist in execution of projects such as method transfers and method validations.
Support activities related to products control systems and health authority filings.
Monitor analytical methods manage reference material replenishment and testing.
Identify and resolve discrepancies as applicable.

Required Skills:

BS/BA degree with 2 3 years of commercial quality control experience (pharmaceutical/biopharmaceutical preferred).
Strong knowledge of GMP quality control systems.
Experience in a relevant scientific discipline.
Strong planning skills for working with cross-functional teams.
Ability to negotiate influence and make decisions to meet objectives.
Excellent verbal and written communication skills with the ability to present formally and informally.
Solid understanding of scientific theories principles and techniques used in analytical and/or biological test procedures.
Demonstrated judgment reasoning and problem-solving skills.
Ability to work with moderate independence or under supervision while managing multiple projects.

Desired Skills

Prior experience in pharmaceutical or biopharmaceutical quality control operations.
Experience with analytical method transfers and validations.
Familiarity with regulatory filings and product life-cycle management.
Demonstrated ability to contribute to process improvements within QC operations.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expert...