Qa Specialist

1-3 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 Specialist – GSK
Location: USA – Pennsylvania – King of Prussia
Posted Date: January 15, 2025

Are you energized by a quality assurance role in a cutting-edge manufacturing environment? At GSK, we’re looking for a QA Specialist to help accelerate compliance in the production of biopharmaceutical products, ensuring they meet local and regulatory standards. This role offers an opportunity to make critical decisions and drive quality systems actions, providing support for new product implementations, audit preparations, and more.

Role Overview:
As a QA Specialist, you will be a key player in the facility’s quality assurance activities, helping to ensure compliance with Good Manufacturing Practices (cGMP) and internal GSK procedures. Your expertise will be critical in reviewing records, guiding teams, and supporting special projects such as validation and new product initiatives. You’ll work closely with cross-functional teams to maintain high standards of quality across the production lifecycle.

Key Responsibilities:

Assist with internal and regulatory audits, preparing summary reports.
Review laboratory and control records for lot release of raw materials, components, and finished goods.
Manage and administer electronic quality systems supporting lot release.
Support special projects like validation, site priorities, and new product implementations.
Assist in data collection and trend analysis, identifying abnormal trends or major issues.
Provide expert knowledge on cGMP, CFR, and other regulatory standards.
Review change management documents and technical documents related to validation and automation.
Support the closure of Quality system records including investigations, corrective actions, and change controls.
Update departmental documents such as Standard Operating Procedures (SOPs).

Basic Qualifications:

BA/BS degree.
3+ years in biopharmaceutical or pharmaceutical industries.
1+ years of experience in quality systems (deviations, validation, documentation, change controls, or auditing/compliance).
1+ years of experience with cGMP.

Preferred Qualifications:

Strong written and verbal communication skills.
Excellent organizational and computer skills.
Ability to work in a team environment and interact effectively with multidisciplinary teams.
Strong decision-making skills and the ability to prioritize actions.

Why GSK?
GSK is a global biopharma company on a mission to unite science, technology, and talent to get ahead of disease and improve lives worldwide. We are committed to fostering an inclusive work environment where everyone is valued and can thrive.

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

Application Instructions:
Please submit your application by January 29, 2025, ensuring you include your CV or cover letter to demonstrate how your experience meets the job requirements.

Why GSK?
At GSK, we unite science, technology, and talent to get ahead of disease together. If you share this vision, join us at this exciting time to make a difference in the health of billions of people worldwide.

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Qa Specialist

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