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Quality Assurance Associate

3 months ago

Elstree, United Kingdom BPL Full time

Bio Products Laboratory (BPL), part of Kedrion, is seeking a Quality Assurance Associate to support the Quality Assurance department. This role plays a crucial part in maintaining quality control measures for sustained operational excellence. Join us in upholding high standards and ensuring a seamless production process.

Whilst ensuring adherence to procedures, policies, and cGMP requirements for QP disposition, you will work collaboratively on the shop floor to guarantee accurate and timely completion of batch records and assist in collating reviewed records and supporting batch disposition decisions.

**This role is on a 24/7 shift - 4 days on, 4 off, 4 nights on, 4 off - 12 hour shifts - 7am - 7pm and 7pm to 7am**

**Duties & Responsibilities -**
- Participate in daily updates for batch release priority.
- To initiate and assist with deviations and changes related to batch review and be able to assess them on behalf of the QP.
- Complete GMP reviews of batch documents in a timely manner in keeping with manufacturing schedules.
- Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.
- To co-ordinate and maintain the files for a range of quality records as required
- To participate as required in Regulatory and customer audits.
- To assist in progression of regulatory actions, customer complaints, GDP incidents where required.
- To perform regular audits of the manufacturing facility and contribute to continuous improvement activities
- To undertake work related to job objectives as directed by QA management.

**Skills & Education required to help you within the role -**
- Education
- Degree level qualification in science discipline or equivalent.
- Skills and Experience
- Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment.
- Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.
- The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise.
- Experience of working with documentation and quality management systems desirable.
- A natural tendency towards continuous improvement is required.
- Experience with blood products is desirable but not essential.

**In return we offer -**

We're looking for highly motivated and experienced people to drive the business forward. In return you'll be supported in developing your skills with ongoing training and career opportunities.
- Competitive salary
- Bonus
- 25 days holiday
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- My Healthy Advantage phone app
- Virtual GP
- Cycle to work scheme
- Subsided canteen