Qa Coordinator

3+ years

Not Disclosed

Remote, USA

10 Jan. 17, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

QA Coordinator – GSK
Location: USA – Pennsylvania – King of Prussia
Posted Date: January 14, 2025

Are you passionate about quality assurance and ready to help accelerate compliance in a cutting-edge biopharmaceutical manufacturing environment? GSK is seeking a QA Coordinator to provide support for the site when implementing new products, reviewing records for regulatory compliance, and ensuring quality systems are executed correctly. This role will be key in maintaining compliance with GSK's internal procedures and global regulatory standards while contributing to the production of biopharmaceutical products.

Role Overview:
As a QA Coordinator, you will work directly with production and operational teams to ensure compliance in the manufacturing of biopharmaceutical products. You will be responsible for reviewing production and control records, administering electronic quality systems, supporting special projects, and ensuring compliance with cGMP and regulatory standards.

Key Responsibilities:

Review production and control records to support the lot release of finished biopharmaceutical products.
Administer electronic systems for lot release, ensuring compliance with established procedures.
Support special projects, including validation, site priorities, and new product tech transfers.
Assist with the completion of annual product reviews and trend analysis reports, identifying abnormal trends or issues.
Collect and evaluate information for internal and regulatory audits and assist with audit preparation.
Apply cGMP, CFR, and other regulations to ensure compliance in quality assurance activities.
Review documents related to change management, equipment and process validation, automation change controls, and computer validation.
Support the closure of quality system records, including deviation investigations, corrective actions, and change controls.
Update departmental documents such as SOPs as needed.
This position will be on the night shift (5 PM – 5 AM), with some holidays and weekends (shift differential compensation provided).

Basic Qualifications:

Bachelor’s degree in Biology, Chemistry, Engineering, Biotechnology, or Computer Science.
1+ years of experience in biologics manufacturing.
1+ years of experience in quality systems (deviation, validation, documentation, change controls, or auditing/compliance).
1+ years of experience with cGMP in the pharmaceutical, testing, secondary repacking, or similar field.
Must be available to work the night shift (5 PM – 5 AM) along with some holidays and weekends.

Preferred Qualifications:

3+ years of experience in biologics manufacturing and quality systems, including validation, documentation, or auditing/compliance.
Strong written communication, organizational, and computer skills.
Effective interpersonal and verbal skills.
Ability to function within a team-based organization and prioritize tasks.
Ability to interact with multidisciplinary teams, including engineering, production, QC, and validation.

Why GSK?
GSK is a global biopharmaceutical company with a mission to unite science, technology, and talent to get ahead of disease. At GSK, we are committed to creating an environment where people thrive. Join us in shaping the future of healthcare, contributing to innovative therapies, and making a positive impact on millions of lives worldwide.

Benefits:
GSK offers a comprehensive benefits package, which you can learn more about on the GSK US Benefits Summary page.

Application Instructions:
Submit your application by January 29, 2025, and include your CV or cover letter detailing how your experience aligns with the role’s requirements.

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Qa Coordinator

Job Description

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