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.
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 desirable
Core Competencies
Agility
* Learns from experience, adapts to change, and embraces new challenges
Business Acumen
* Understands how their role contributes to business success
Collaboration
* Shares knowledge, listens actively, and respects others
Customer Focus
* Understands and responds to internal/external customer needs
Driving Results
* Delivers high-quality work on time, monitors KPIs, and overcomes challenges
Leadership
* 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