Senior Quality Specialist job Exton Pennsylvania
Senior Quality Specialist job Exton Pennsylvania
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Senior Quality Specialist Job

Employer Name: SpiderID: 8068796
Location: Exton, Pennsylvania Date Posted: 10/17/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH28139

Job Description:

Job Summary

  • The Sr. Quality Specialist - Quality Systems will have Quality Assurance functions within the Biologics Pilot Plant, to ensure adherence with cGMPs, EMEA, ICH and JP regulations within this human health care pharmaceutical company.

This individual will provide quality support for clinical and commercial production activities including:

  • Computer systems such as LabVantage LIMS, TrackWise, and SAP throughout their respective system lifecycles. This includes LIMS master data load, SOP generation/updating, and system validation activities such as test script execution and user support.

  • Incoming Goods Program including supplier assessments, vendor change notifications, deviation/CAPA investigation and resolution, SOP generation/updating, as well as batch review and disposition.

  • Bulk Drug Substance disposition for Biologics Pilot Plant manufacturing as well as Contract Manufacturing Operations including SOP generation/updating, review of batch records, test results, and analytical method validation/qualification protocols and reports.

Scope Measures

  • This position will provide quality support for project management, administration, validation, and change management for global and regional QA Information systems to ensure regulatory and corporate compliance.

  • Additionally, this position will ensure adherence to Quality specifications and standards for incoming goods and Bulk Drug Substance manufactured at the Biologics Pilot Plant as well as approved Contract Manufacturing Organizations.


  • Provide support for computer systems managed by Quality to ensure compliance of systems with applicable regulations, company policies and procedures including LIMS master data load, system administration, validation, SOP management, user support, training and change management. 40

  • Provide support for Incoming Goods activities including supplier approval process, supplier change notifications, specifications, SOP management, batch file review, deviation/CAPA investigation/resolution and material disposition. 30

  • Provide quality support for disposition of Bulk Drug Substance manufactured at the Biologics Pilot Plant. Responsibilities include SOP management, review of batch records, batch files, LIMS genealogy, deviations, testing including analytical method validation/qualification and batch certificate generation. 20

  • Provide Quality oversight at cross functional team meetings, attend GMP and safety trainings, complete read and understand training by due dates and participate in internal audits. 10

Knowledge/Skills/Abilities Required

  • BS/BA in Life Sciences, Computer Science or equivalent.

  • Minimum 5 years' experience in FDA or equivalent regulated industry, biotechnology or pharmaceutical, performing Quality Assurance related functions such as batch record review, SOP and protocol writing, auditing, quality specification development, batch release functions, deviation investigation and resolution, auditing, etc.

  • Minimum 3 years' experience working with SAP, Trackwise, LIMS, eDMS; preferred working knowledge of SharePoint.

  • Effective written and verbal communication and organizational skills.

  • Knowledge and experience in ICH guidelines, FDA, EMEA and JP regulations as they pertain to commercial and clinical manufacturing of antibody based bio therapeutics.

  • Experience working in a GMP environment is required; experience working in a biologics Pilot Plant facility is preferred.

  • Good problem solving and interpersonal skills with the ability to interact with global multidisciplinary team members.

  • Organizational skills needed to manage multiple competing projects is required.

Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.

Approx. Duration: 12 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center:

Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.

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