Quality Assurance Associate - Biotechnology

Quality Assurance Associate - Biotechnology at Insight Global Quality Assurance Associate - Biotechnology at Insight Global in Southeastern, Pennsylvania Posted in about 1 hour ago.

Type:

full-time

Job Description:

Quality Assurance Associate Job Opportunity Location :

Fully Onsite in

Malvern, PA Shift:

1st Shift (M-F)

Compensation:

$33.65/hr to $38.46/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law. Required Qualifications Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry, Microbiology, or related field) Minimum of 2 years of experience in a GMP pharmaceutical or biotechnology environment Experience in QA, QC oversight, raw material release, or laboratory data review Strong understanding of GMP documentation and regulated quality systems Ability to read, interpret, and apply SOPs, work instructions, test methods, and protocols Demonstrated critical thinking, problem?solving, and sound judgment Comfort working in a fully on?site environment and collaborating cross?functionally Preferred Qualifications Experience reviewing Certificates of Analysis (CoAs) Exposure to raw material quality, supplier quality, or warehouse QA oversight Experience using SAP in quality or release workflows Familiarity with LIMS or laboratory data systems Experience supporting commercial GMP manufacturing environments Position Summary The Quality Assurance Associate provides QA oversight and release support for raw materials and related quality activities across laboratory, warehouse, and supplier?facing functions. This role supports raw material release, Certificate of Analysis (CoA) review, and quality oversight activities, while also providing flexible support to other QA operational needs as business priorities evolve. This position is intentionally designed to be cross?trained, supporting multiple QA functions rather than a single, siloed task. The role does not independently author investigations or CAPAs, but contributes to quality decision?making through documentation review, issue identification, and appropriate escalation. Key Responsibilities Raw Material Release & QA Oversight Perform QA review of raw material documentation, including Certificates of Analysis (CoAs), supplier test data, and associated data packages Support raw material disposition and release activities in accordance with GMP requirements and internal quality systems Review internal and external laboratory testing data supporting material release decisions Cell Banking / CoA Review Support Support QA review and approval workflows for Cell Banking CoA documentation Apply transferable release and data review skills across both raw material and cell banking processes Supplier & Program Quality Support Provide QA oversight support for supplier quality programs, including origin bag and related material programs Partner with other QA teams to support shared quality responsibilities across organizations Identify documentation gaps, quality risks, and compliance concerns and escalate appropriately Inspection & Sampling Oversight Provide QA oversight support for QC inspection and sampling activities occurring in warehouse or laboratory environments Review inspection documentation to ensure adherence to procedures and regulatory expectations General QA Operations Support Support additional QA operational activities as assigned, excluding independent deviation, investigation, or CAPA authorship Participate in cross?training to ensure coverage across multiple QA functions Maintain compliant training status and adhere to cGMP, safety, and quality system requirements