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QA Associate

Slough
1 week ago
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QA Associate
Location: Slough (Fully Onsite)
Contract Length: 9 months (with potential to extend)
Pay Rate: £21.92 per hour

Role Purpose & Scope

As a member of the QA Operations Documentation Control Team, your primary responsibility will be to perform Batch Consolidation (auditing) for QC Biochemistry and Microbiology testing activities related to Drug Product (DP) and Drug Substance (DS). You will ensure all QC testing activities are complete and meet release specifications. You will also proactively issue GMP documents and labels to Manufacturing in line with schedules and timelines.

Key Responsibilities

Coordinate and perform batch consolidation for QC Biochemistry and Microbiology testing.
Ensure all testing activities are complete and meet release specifications.
Issue GMP documents and labels to Manufacturing, ensuring accuracy and timeliness.
Liaise with internal departments to gather required information and maintain effective communication.
Support QA Operations in continuous improvement of quality systems and processes.
Assist in audit preparation and provide documentation during audits.
Lead and manage quality records (Deviations, CAPAs, Change Controls, Investigations).
Author, review, and approve GMP documentation.
Maintain the archiving system and coordinate document retrieval.
Ensure training compliance and maintain an up-to-date training profile.
Prioritise workload to meet strict deadlines and support Manufacturing needs.
Perform other duties as assigned.

Key Stakeholders

Quality Control
Manufacturing
Quality Assurance & Qualified Persons (QPs)

Required Skills & Competencies

Technical & Interpersonal Skills

Strong attention to detail and accurate data entry
Proficiency in MS Office (Word, Excel, Outlook, Access)
Familiarity with database systems
Effective verbal and written communication
Risk-based decision-making
Ability to prioritise workload and meet deadlines
Strong organisational and planning skills
Experience with PQS (Pharmaceutical Quality Systems) is desirableCore Competencies
Agility

Learns from experience, adapts to change, and embraces new challengesBusiness Acumen

Understands how their role contributes to business successCollaboration

Shares knowledge, listens actively, and respects othersCustomer Focus

Understands and responds to internal/external customer needsDriving Results

Delivers high-quality work on time, monitors KPIs, and overcomes challengesLeadership

Takes responsibility, seeks feedback, and contributes to a positive work environment

Qualifications

Education: BSc in Biology or a related field (or equivalent experience)
Experience: Entry-level (0-4 years); prior QA/GMP experience is beneficial but not essential

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy

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