Specialist, R&D Frontline QA

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Nov 10, 2021
Ref
R-141792
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Summary

This position in R&D QA provides frontline QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Holly Springs, NC and related changes and deviations.  Provides support in Holly Springs for assuring quality during GMP clinical manufacturing activities. As required also supports the R&D QA batch disposition teams.

Principal Accountabilities

Provide Quality oversight of R&D activities

  • Provides QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required

  • Reviews executed batch records, development/validation/qualification protocols for compliance and completeness.

  • Ensures data integrity by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.

  • Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP)

  • Supports the development and implementation of standard operating procedures (SOPs), work instructions and batch production document(s) governing GMP production and QA oversight activities

  • Identifies non-compliances with GMP production of bulk and semifinished material and reports as appropriate.

  • Performs minor deviations investigations and product technical compliant investigatons

  • As needed supports R&D QA batch disposition activities

  • Supports the implementation of the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations, and identified areas for continuous improvement

Establishes relationships with R&D QA and other global Quality functions:

  • Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets

Helps maintain the Quality System in R&D

  • Identifies and escalates risks to compliance to senior management

  • Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities

  • Supports internal audits and helps prepare for regulatory inspections

  • Supports inspection finding responses related to applicable area of oversight

  • Supports the provision of accurate and timely reports on metrics, findings, risks and trends

Qualifications

  • Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy)

  • 0+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry

  • Previous work in a QC, Research, Development, Manufacturing or Quality perferred

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

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