Quality Assurance Associate
Bionical Emas
- Hitchin, England, United Kingdom
- Hitchin, England, United Kingdom
About
At Bionical Emas you will have the chance to develop your career with an outstanding team in a welcoming, flexible, and supportive culture that values trust and belonging.
About the Role QA Associate – assisting the QA team with the company’s quality assurance functions, including the Quality Management System (QMS). Ensure compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) and drive continuous improvement to meet regulatory and 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 GDP 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.
A‑level or higher educational qualification is essential.
Experience with GMP/GDP and a QMS is essential.
Must be able to be site‑based at our Burton‑On‑Trent site.
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 to build inclusive culture.
Flexible and hybrid work.
We are Bionical Emas
We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives whatever the corporate or personal goal and all individuals and organisations are respected and celebrated.
We do not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related conditions), gender identity or expression, sexual orientation, marital status, military service, veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable law. Bionical Emas management team is dedicated to this policy throughout recruitment, hiring, promotion, training, compensation, benefits and employment practices.
Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with disabilities. If you need accommodation, please email the recruitment team.
Protecting your privacy and the security of your data is a top priority. Please consult our Privacy Notice. By applying, you confirm you have reviewed and agreed to our Data Privacy Notice for Candidates.
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Languages
- English
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