What are the responsibilities and job description for the Senior Quality Assurance Associate position at Advanced Clinical?
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Quality Assurance Associate in Raleigh, North Carolina. The Senior Quality Assurance Associate role will play a critical role for data management of commercial biologics executed by contract laboratories. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
1. Data review, data management to support use of electronic systems such as Veeva Quality eDocs,
Minitab.
2. 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.
3. Monitoring release and stability data to ensure data integrity, regulatory compliance, product
quality, and on-time completion.
4. Acting as the technical reviewer of data sets, quality records and lab investigations generated by
contract test labs.
5. Authoring CoAs, technical reports, internal quality records in accordance with regulatory
requirements.
6. Serving as the SME for product specific test methods for internal and external quality control.
7. 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.
8. 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.
9. Supporting analytical method validation and method transfer activities.
Requirements
EXPERIENCE
- 3 years of pharmaceutical / biotech working experience in a cGMP Quality Control, analytical
development, analytical transfer, or validation department in an FDA-regulated industry.
which may include HPLC, CE, PCR, ELISA, gel-based assays and other compendial assays used to
test biopharmaceuticals.
EDUCATION
Associate degree (required); BS / BA in pertinent life sciences or closely related field (preferred)
To be a best-fit your strengths must include :
Laboratory compliance, data integrity, and quality events.
plus.
and / or decisions.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http : / / www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
