Quality Assurance Associate - Senior Job at Zenith LifeScience, Raleigh, NC

bFpoT1NITWFJNEpZZHhldThmZVVaWVA5S2c9PQ==
  • Zenith LifeScience
  • Raleigh, NC

Job Description

Quality Assurance Associate – Senior

Location: Raleigh, NC (hybrid role – 2 days onsite; 3 days WFH)

Duration: 12 Months

Job Description :

The Contractor Quality Associate, Biologics 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

Essential Functions :

Data review, data management of routine testing executed by contract laboratories for commercial

Biologics including:

  • 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 :

Education:

  • Associate degree (required); BS/BA in pertinent life sciences or closely related field (preferred)

Technical:

  • 4+ 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.

Must Possess:

  • 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 Company Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of Company’s hhc Mission and the need to always think first of the Patient

Job Tags

Contract work, For contractors, Work experience placement,

Similar Jobs

C.R. England

CDL-A Regional Truck Driver - 3 Months Experience Required Job at C.R. England

If you an experienced solo CDL driver looking for a better carrier, drive for C.R. England, the premier long-haul refrigerated carrier in the country. This Regional fleet delivers no-touch freight to the lower 48 states. Valid CDL-A plus 3+ months of Class A CDL experience... 

Hyatt

Hotel Bartender Job at Hyatt

 ...providing efficient service and meaningful experiences. Bartenders are responsible for providing libations and offering customized...  ...". Benefits include: ~ Complimentary & Discounted Hyatt Hotel Rooms ~ Paid Time Off (PTO)~401(k) Match ~ Medical, Dental... 

Chicago Public Schools

Be a School Counselor at Chicago Public Schools Job at Chicago Public Schools

Description: Thank you for your interest in being a School Counselor with Chicago Public Schools! We have opportunities across the city to support thousands of students. Submit your information here if you have a teaching certificate in Illinois (endorsed as a school...

K&K METAL RECYCLING, LLC

Truck Driver Class A CDL Job at K&K METAL RECYCLING, LLC

 ...recycling center for many years. At KKMR we take pride in what we do and the services we offer. We are looking for a Class A CDL Truck Driver who will be responsible for local pick-up and delivery of scrap metal. Home Daily. Duties: Pick-up scrap metal... 

The Oncology Institute, Inc.

Hematologist oncologist Job at The Oncology Institute, Inc.

 ...Growing Patient Demand & Diverse Population With an aging population and multicultural community, theres a high demand for oncologiststo treat in both urban and community-based settings. High Quality of Life San Diego is consistently ranked among the best places...