QA Specialist Drug Product
Kelly Scientific Resources is excited to present a six-months contract QA Specialist Drug Product opportunity at a pharmaceutical company that specialize in respiratory diseases, metabolism, immunology, oncology and diseases in the central nervous system located in Fremont, CA.
Responsible for the tactical execution of quality assurance oversight activities of the assigned area which may include oversight of any area of the business responsible for adhering to current good manufacturing practices (cGMPs) including warehouse, manufacturing processes, inspection, batch record review, batch disposition, new product introduction/product transfer, and QC laboratories. This includes timely identification of events impacting the Quality of products and processes evaluate situation for potential impact, work with junior staff to assess the event, and notify appropriate senior staff or management for further assessment as needed. QA oversight responsibilities include creating and/or revising SOPs, ensuring adherence to SOPs and requirements, proper change management, supporting corrective action and preventive action plans (CAPA)/Deviation management, and to ensure documentation and/or investigations meet company and regulatory standards. Oversight is assured through close attention to activity execution close to the assigned area and mentoring of junior staff including consistent support (i.e., Cell Culture, Purification, Formulations, Filling, other Technical Areas, Laboratories, etc.). This also includes identification of potential continuous improvement ideas. Provides strong quality oversight and consultation to ensure compliance with cGMP's, regulatory, industry, and corporate requirements.
This position will primarily support Drug Product, Packaging, and Logistics areas.
- Minimum of intermediate knowledge of relevant regulations and guidance (i.e. cGMPs, SOPs, Protocols).
- Strong attention to detail, interpersonal skills including conflict resolution/negotiation, organizational/time management skills, verbal/written communication skills, ability to work in a team environment, effective problem-solving, and ability to identify and escalate issues when necessary.
- Bachelor's Degree in Life Sciences OR
- In lieu of a Bachelor's Degree, a High School Diploma will be considered with a minimum of two (2) years quality pharmaceutical industry experience with cGMPs in areas described in this profile.
Why Kelly **** ?
With Kelly, you'll have access to some of the world's highest-regarded scientific organizations-providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career-connect with us today.
AboutKelly Services ****
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.