CSL Plasma
Sr Specialist R&D QA Shop Floor - M-F 8-5 not shift work
At a glance
Location: US-NC-Holly Springs Map
Posted: 11/10/2021
Closing: 12/09/2021
Degree: 4 Year Degree
Type: Full-Time
Experience: Not Specified
CSL Plasma
Job description
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, liaising with site colleagues to align on the preferred approach for proposal to stakeholders. Supports the development and maintenance of quality procedures and systems related to area of expertise.

Major Accountabilities:

Provide Quality oversight of R&D activities

  • Ensures bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.

  • Supports the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.

  • Reviews and approves executed batch records and development/validation/qualification protocols

  • Ensures data integrity and 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)

  • Authors phase appropriate FLQA procedures for oversight of clinical manufacturing 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

  • Provides QA oversight to level 0 changes and minor deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations

  • 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:

  • Advises R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues

  • 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

Minimum Requirements:

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

  • 3+ 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 role required.

  • Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)

  • Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)

  • Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving

  • Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product

  • Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change

  • Effective verbal & written communication skills in a cross functional environment with attention to detail

  • Ability to present solutions to complex and strategic issues

  • Evidence of commercial awareness in technical strategies

  • Excellent customer focus with demonstrated management of customer expectations

  • Effective presentation skills

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.

Do work that matters at Seqirus!

Sr Specialist R&D QA Shop Floor - M-F 8-5 not shift work