Quality Assurance Associate

Bionical Emas; Long Eaton; On-site; GBP 30,000 - 40,000; Full time

Job summary

A global clinical trial supply company in the UK is seeking a QA Associate to enhance quality assurance functions and maintain compliance with industry regulations. Responsibilities include supporting the QA team, overseeing the Quality Management System, and managing change controls. The ideal candidate should hold a relevant scientific degree and possess experience in GMP/GDP. Benefits include flexible work arrangements, health insurance, and a generous vacation package.

Benefits

25 days of vacation

Discretionary Annual Bonus

Flexible and hybrid work

Health Insurance

Life Insurance

Qualifications

• GMP/GDP experience is essential.
• Experience with a QMS is advantageous.
• A scientific degree is beneficial.

Responsibilities

• Support the Senior QA Manager in improving the QMS.
• Ensure compliance with MHRA, GDP, and GMP standards.
• Manage change requests and communicate effectively with stakeholders.
• Log and close CAPAs resulting from audits and inspections.

Skills

GMP experience

QMS experience

Scientific knowledge

Attention to detail

Education

A-level or higher educational qualification

Scientific degree in pharmacy, pharmaceutical sciences, chemistry, biology or related

Job description

We are looking for a QA Associate to join the team and be responsible for assisting in the provision of the company's quality assurance functions, including the company's Quality Management System (QMS). Ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) & driving continuous improvement to ensure compliance with all relevant regulatory, best practice & company requirements.

Responsibilities

• Support the Senior QA Manager and wider QA team in building, maintaining, and continuously improving a robust, compliant QMS
• Ensure the QMS meets all MHRA licence requirements, GDP/GMP standards, and relevant international regulations (including FDA) at all times
• Raise and manage change requests affecting GMDP activities and communicate required change controls to external stakeholders
• Log, track, and close CAPAs arising from audits, inspections, complaints, deviations, and self-inspections, including communicating outcomes externally where needed
• Investigate and document minor non-conformances, ensuring appropriate CAPAs are recorded and completed
• Qualify customers and suppliers appropriately, including verifying licences, reviewing questionnaires, and gathering documentation for CTS transactions
• Maintain document control and ensure accuracy, accessibility, and compliance of all quality records, including training documentation
• Assist with training on SOPs/controlled documents and support compliance with all internal systems, processes, and standards
• Manage operational quality tasks such as Fresh Desk ticket allocation, monthly temperature report reviews, and calibration schedule compliance
• Handle product quality and regulatory activities including BSE/TSE assessments, GMP evidence collection, recall coordination, and creation/approval of customer quality statements

Qualifications

• Scientific degree, ideally pharmacy, pharmaceutical sciences, chemistry, biology or related would be advantageous
• A-level or higher educational is essential
• GMP/ GDP experience is essential
• Experience with a QMS
• Location: Site based in Burton‑On‑Trent

Benefits

• 25 days of vacation
• Vacation days purchasing scheme
• 1 extra vacation day per each 3 years of service
• Discretionary Annual Bonus
• Sabbatical of 3 to 6 months (after 2 years of service)
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Employee Support Networks – help us continue to build on our inclusive culture
• Flexible and hybrid work

We care about our people's well‑being, their personal development and providing a true work‑life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us.

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life‑changing medicines to patients around the world. Their range of services and capabilities benefit many of the world's leading pharma and biotech companies.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we'd love to hear from you.