Quality Control Associate I

Software Guidance & Assistance, Inc., (SGA), is searching for a Quality Control Associate I for a contract assignment with one of our premier Pharmaceutical clients in South San Francisco, CA.

Responsibilities :

• The job responsibility within the PTDA Bioassay US Testing Group is to perform biochemical/immunological and cell-based assays in support of clinical and to-be-marketed products.
• Will support process development, product characterization, stability, and lot release testing with established procedures in a cGMP environment.
• Responsibilities include, but are not limited to, compliance review and release of assay data (electronic and paper-based), preparing reagents, presenting results, and monitoring assay quality.
• Expectations include Good Documentation Practices, demonstrating ALCOA+ principles, data integrity, routine lab maintenance, supporting 5S, and following EHS safety practices.

Required Skills:

• B.S. in Biological Sciences with at least 1-2 years of relevant experience in Quality Control
• Hands-on experience with performing immunological or cell-based assays
• Experience with aseptic cell culturing and cGMP knowledge is required
• Ability to work independently as well as with a team, handle multiple projects, demonstrate initiative while maintaining exceptional attention-to-detail
• Demonstrate effective verbal and written communication skills in a fast paced environment
• Required proficiency in computer applications, data management, and electronic documentation systems.

Preferred Skills:

• Prior experience with GxP-compliant systems such as global SoftMax Pro, Single LIMS, and Veeva QMS is highly preferred.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
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