Highlights
Master's Degree and 4+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR Bachelor's Degree and 6+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR High School Degree and 10+ years' experience in a Quality function in the pharmaceutical or biotechnology industry. This role will support the Product Quality function reporting to the Director of Analytical Method Lifecycle and Trending but work cross functionally with global and site-based QC SMEs, and other departments within Technical Operations.
Numbers & Facts
| Location | El Segundo, CA |
| Industry | Computer/IT Services |
| Salary | $46–$51 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
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Job Title: Sr. Quality Control (QC) Specialist
Location: El Segundo, CA 90245
Duration: 10 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Description:
- Everyone at Client is grounded by one common goal curing cancer.
- Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
- We are in search of a highly motivated individual to join us as a Sr. Quality Control (QC) Specialist, located at our Santa Monica, California location.
- This role will support the Product Quality function reporting to the Director of Analytical Method Lifecycle and Trending but work cross functionally with global and site-based QC SMEs, and other departments within Technical Operations.
Responsibilities (include, but are not limited to):
- Execute global reporting control and invalid trending programs.
- Execute data extraction from LIMs system to support reporting requirements.
- Lead/coordinate continuous improvement activities partnering with sites.
- Author Annual Product Review Laboratory Section.
- Author technical quarterly invalid and biannual control trending reports.
- Interact with the laboratory operations group to support new methods, technology, and KLIMS implementation and ongoing support for new module implementations and/or installation of new capabilities.
- Meet reporting deadlines as defined per procedure demonstrating organizational, prioritization, and time management proficiencies.
- Highly effective written and oral communication skills to address a cross-functional audience.
- Self-motivated, detail-oriented, and willingness to support other team members.
- Improve processes to minimize complexities and optimize operational effectiveness.
- Proficient with statistical tools such as JMP and/or Minitab.
- Proficient in Microsoft Office application.
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, GLP.
Basic Qualifications:
- Master's Degree and 4+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR Bachelor's Degree and 6+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR High School Degree and 10+ years' experience in a Quality function in the pharmaceutical or biotechnology industry.
Preferred Qualifications:
- Experience with gene and cell therapies or pharmaceutical industry.
- Statistical knowledge in biologics is a plus.
- Able to adjust workload based upon changing priorities.
- Experience in Risk Management processes a plus.
- Experience with international health authority inspections a plus.
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TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.