Job Description
The Opportunity: Global pharmaceutical company in Raleigh, NC seeks a
Senior Quality Assurance Associate to join their team. This is a long-term, temporary position, Monday - Friday, 40 hours per week. The position is hybrid with two days onsite; three days WFH. The hourly rate is $50-$65 plus benefits.
Primary Duties: The
Senior Quality Assurance Associate plays a critical role for data management of commercial biologics executed by contract laboratories. The position requires familiarity with data review, data management in Excel or Minitab, understanding of LIMS system. Some understanding or familiarity with bioanalytical methods such as, but not limited to, compendial, HPLC, ELISA, CE, real time PCR, spectrophotometry, SDS-PAGE, HPLC methods, is valuable. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. The primary duties include but are not limited to:
- Data review, data management to support use of electronic systems such as Veeva Quality eDocs, Minitab.
- Perform and support data trending, interpretation and statistical analysis of commercial release and stability studies, for assay controls or reference standards and invalid assay trending.
- Monitoring release and stability data to ensure data integrity, regulatory compliance, product quality, and on-time completion.
- Acting as the technical reviewer of data sets, quality records and lab investigations generated by contract test labs.
- Authoring CoAs, technical reports, internal quality records in accordance with regulatory requirements.
- Serving as the SME for product specific test methods for internal and external quality control.
- Collaborating frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities. These groups include
- CMOs/contract test labs, manufacturing operations, quality, regulatory and program management.
- Monitoring product specific reference standard programs in collaboration with the network
- Analytical/Quality experts to sustain routine testing activities. This includes driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.
- Supporting analytical method validation and method transfer activities.
Requirements - Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)
- 3+ years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry.
- Familiarity with data trending and monitoring controls.
- Hands-on experience within a bioanalytical lab. Familiarity with equipment and test methods which may include HPLC, CE, PCR, ELISA, gel-based assays and other compendial assays used to test biopharmaceuticals.
- Familiarity with Method Validation, Analytical Transfers, or laboratory investigation experience.
- Thorough understanding of principles, practices, and standards for biopharmaceutical testing.
- Well versed in ICH and regulatory requirements for quality as it relates to QC operations, Laboratory compliance, data integrity, and quality events.
- Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus.
- Proficient in Microsoft Office tools, Minitab, Veeva Quality systems.
- Strong organization and communication skills and technical writing skills.
- Must be self-directed, goal-oriented, and quality conscious.
- High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions.
- Values consistent with the Company's Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of the Company's hhc Mission and the need to always think first of the Patient
The Partnership – Benefits:
ABA-MEC Medical Benefit
PEP 401k
Paid Time Off
Employee Assistance Program (EAP)
Working Advantage {discounts)
Financial Wellness Program (FinFit)
Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all qualified applicants will receive consideration for employment without discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.
Job Tags
Hourly pay, Full time, Contract work, Temporary work, Work experience placement, Monday to Friday,