GMP Quality Assurance Associate

LanceSoft UK; Slough; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a dedicated QA Associate to ensure compliance with quality standards in a fully onsite role. This position involves managing GMP issues, reviewing documentation, and supporting continuous improvement initiatives. The ideal candidate will possess a strong background in quality assurance and a Bachelor’s degree in Biology or a related field. Join a dynamic team that values attention to detail and organizational skills, and contribute to the delivery of high-quality products in the biotechnology and pharmaceutical sectors.

Qualifications

• Experience in GMP and quality procedures.
• Ability to mentor colleagues in cGMP practices.

Responsibilities

• Review documentation from manufacturing and laboratory processes.
• Identify and resolve non-conformances using GMP procedures.

Skills

MS Office proficiency

Database management

Verbal communication

Written communication

Risk-based decision making

Attention to detail

Workload prioritization

Organizational skills

Education

Bachelor of Science in Biology

Equivalent degree in related field

Tools

Quality Management Systems (QMS)

Job description

This range is provided by LanceSoft UK. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Direct message the job poster from LanceSoft UK

Director Delivery Services at LanceSoft, Inc.

Role: QA Associate

Location: Slough, Berkshire SL1 4DX

Duration: 9-month role with potential to extend

Fully onsite position

Description

Role Purpose & Scope:

• Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership.
• Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets.
• This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes, and escalating non-compliance through PQS, site governance mechanisms, and senior QA Leadership as needed.
• Support Senior QA leadership to drive continuous improvement.
• Maintain compliance with Regulatory Authorities requirements, Global Quality standards, and client’s Customer expectations.

Key Responsibilities

• Review documentation generated during manufacturing, development, and laboratory processes.
• Advise on best practices for document completion, review, follow-up actions, and escalation if required.
• Serve as a point of contact for general Quality queries and escalate as needed.
• Identify, report, and resolve non-conformances using GMP and quality procedures, including deviations and CAPAs.
• Participate in continuous improvement activities and mentor colleagues in cGMP practices.
• Maintain audit readiness and contribute to PQS process improvements.

Key Stakeholders

Interactions with:

• Manufacturing
• Material Science and Technology (MSAT)
• Supply Chain

Required Skills & Competencies

• Proficiency with MS Office and database management.
• Strong verbal and written communication skills.
• Risk-based decision making.
• PQS experience.
• Attention to detail and accurate data entry.
• Workload prioritization and decision-making skills.
• Ability to meet strict deadlines.
• Organizational and planning skills.

Education/Degree

• Bachelor of Science (or equivalent) in Biology or related field.

Seniority level

• Associate

Employment type

• Contract

Job function

• Quality Assurance, Science, and Research

Industries

• Biotechnology Research and Pharmaceutical Manufacturing