QA Officer - Biotechnology

Russell Taylor Group Ltd; Alderley Edge; On-site; GBP 28,000 - 33,000; Full time

Job summary

A biotechnology firm in Alderley Edge seeks a QA Officer/Specialist to enhance their QA team. The role involves generating SOPs, supporting customers, conducting investigations, and ensuring compliance with GMP. Ideal candidates will have a degree in a relevant scientific discipline and experience with CAPA and deviations. The position offers a salary between £28,000-£33,000 and additional benefits including 25 days holiday and private medical care.

Benefits

25 days holiday + bank holidays

Private medical insurance

Company pension

Share options scheme

Qualifications

• Degree in a relevant scientific discipline.
• Good knowledge of GMP.
• Experience in CAPA, Deviation, OOS, OOT; Internal auditing preferred.

Responsibilities

• Generate or review SOPs and documents as required.
• Support customers and conduct product investigations.
• Participate in the internal audit programme to ensure GMP compliance.

Skills

GMP knowledge

Interpersonal skills

Report writing

Strong IT skills

Education

Degree in relevant scientific discipline

Tools

Microsoft applications

Job description

Overview

QA Officer/ Specialist - Biotechnology

Location: Cheshire (onsite)

Type: Permanent

Salary: £28,000-£33,000 (dependent on experience)

Hours: Days (Monday - Friday), 08:00 - 16:30, Parking on site

Additional: 25 days holiday + BH, private medical, share options scheme, company pension

Our client, a biotech company, is looking to strengthen their QA team and recruit an experienced QA Specialist.

Responsibilities

• Generation or review of SOPs and other documents (where applicable).
• Provide support to customers, answer queries and conduct product investigations.
• Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses and resolution.
• Participate in the internal audit programme to ensure continued GMP compliance of all site activities.
• Utilise scientific resources to work on improving quality of products and services.
• Maintain personal training folder in an auditable state.
• Maintain quality documentation system.
• Participate in quality improvement initiatives.
• Support in the process of maintaining and archiving documentation.
• Support and execute external audits where applicable.
• Support management when hosting regulatory audits.
• Work on executing and maintaining the QMS, including but not limited to:

• Risk Assessments
• Change Controls
• CAPAs
• Deviations
• Complaints
• Recalls
• OOS/OOT

Key Requirements

• Degree in a relevant scientific discipline.
• Good knowledge of GMP.
• Experience in CAPA, Deviations, OOS, OOT; Internal auditing (preferred); Customer complaints handling would be advantageous.
• Strong IT skills (Microsoft applications).
• Good interpersonal skills and strong written/verbal report writing skills.

Important Information

We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us.