QA Associate
LOCATION:
Slough (Onsite)
SCHEDULE:
Standard Office Hours
DURATION:
9-Month Contract
PAY:
26-31 GBP per hour
Job Responsibilities:
In this role, you will support the Quality Assurance Operations Documentation Control team, focusing on batch consolidation and auditing related to QC Biochemistry and QC Microbiology testing for Drug Product (DP) and Drug Substance (DS). Key responsibilities include:
- Performing batch consolidation (auditing) to ensure all QC testing activities are completed and specifications met.
- Coordinating with internal departments to issue documents and labels to Manufacturing according to defined schedules.
- Supporting audit readiness and participating in projects to enhance quality systems and processes.
- Reviewing and approving GMP documentation and managing quality records such as deviations, CAPAs, change controls, and investigations.
- Issuing GMP-compliant documents, labels, and logbooks for manufacturing use.
- Maintaining archiving systems and ensuring compliance with GMP procedures.
- Collaborating closely with internal teams including Quality Control, Manufacturing, and Quality Assurance.
Essential Duties and Job Functions:
- Liaise with internal stakeholders to gather required documentation and maintain strong communication across departments.
- Independently verify testing completion and release readiness for Drug Product and Drug Substance batches.
- Prepare and issue accurate GMP documentation and labels for manufacturing processes.
- Assist with audit preparation and provide documentation during internal or external audits.
- Identify non-conformances and support resolution processes.
- Lead and manage quality records (e.g., CAPAs, deviations, investigations).
- Author, review, and approve controlled documents in line with GMP standards.
- Prioritize and manage workload to meet strict deadlines.
- Maintain personal training compliance before undertaking new responsibilities.
- Perform other duties as assigned.
Required Skills & Competencies:
- Proficient in MS Office (Word, Excel, Outlook, Access); database familiarity preferred.
- Strong verbal and written communication skills.
- High attention to detail with accurate data entry skills.
- Demonstrated ability to prioritize workload and meet deadlines.
- Understanding of risk-based decision-making.
- Experience with Pharmaceutical Quality Systems (PQS) is an advantage.
- Strong organizational and planning abilities.
Core Competencies:
Agility:
Willingness to learn, adapt, and take on new challenges.
Business Acumen:
Understands business area goals and contributes to improvements.
Collaboration:
Works effectively with team members and stakeholders.
Customer Focus:
Delivers high-quality service and responds to feedback.
Driving Results:
Meets KPIs, ensures quality, and consistently delivers.
Leadership:
Takes accountability, seeks feedback, and contributes positively to team culture.
Education & Experience:
- Required: BSc in Biology or related scientific field (or equivalent experience).
- Experience: Prior experience in a QA/GMP environment is beneficial but not essential.
- Level: Entry-level (0–4 years).
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