QC Scientist

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Job description

Kelly Services is currently seeking a QC Scientist for a Direct Hire role in Mountain View.

Job Title: QC Scientist

Pay: $96 - 105k depending on experience

Job Description:

The Quality Control Scientist will be a member of the Quality Control Department. As a Senior Member of the team he or she will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle.

Essential Functions and Responsibilities:
Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients.
Support routine GMP testing as assigned. Mentor and train team members
Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements.
Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports.
Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data.
Identify, evaluate, and implement continuous business process improvements.
Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS).
Provide support during laboratory investigations.
Train QC personnel during method transfer and validation. Provide support during equipment qualification.
Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices.
Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures.

Qualifications:
B.S in Analytical Chemistry or other scientific field; MS/Ph.D. in Analytical Chemistry preferred

8-10 years of experience in the areas of method development, validation, and transfer

Demonstrated experience in Quality Control laboratories for biotechnology products.
Direct GMP Experience

Proficiency in project management skills and tools
Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc.
Must have extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs.
Must be familiar with GMP lab environment and Aseptic techniques.

Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required.
Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution
Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team.
Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.
Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external.

Supervisory Responsibility:
Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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