Software Guidance & Assistance
Quality Control Associate I
Software Guidance & Assistance, South San Francisco, California, us, 94083
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.
LI-PA2 #J-18808-Ljbffr
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.
LI-PA2 #J-18808-Ljbffr