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  • Job reference: RMS0169922

Senior Quality Assurance Associate

  • Sector: Oil & Gas
  • Location: Billingham
  • Job type: Contract
  • Date posted: 25/07/2016
  • Time left:
    d h m s
This vacancy has now expired.
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The Company:
One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .

The Role:

Fully Competent in the operation and maintenance of QA systems, for example Document Control and Issue, Change Control, Investigations and Corrective & Preventative Actions (CAPA), Materials Assurance, Auditing, Qualification and Validation, Manufacturing and QC documentation review and Training.
Pro-actively interacting with the systems to drive continual improvement.

• Principles and application of Good Manufacturing Practice (GMP)
• Auditing
• Written and verbal communication
• Training & Coaching
• Sound judgement in Quality issues
• People supervision


1. Operate core QA deviation, non conformance, change control, document review, auditing and training processes as instructed by QA Management.
2. Ensure self and direct team (including line reports) have no overdue training, or site actions. Support other QA teams in completion of site actions.
3. Supervise, motivate, train, and coach, any direct reports to ensure assigned Quality Assurance (QA) and personnel development objectives are achieved within agreed time-scales.
4. Able to coach/train personnel of directly interfacing non-QA roles, in the application of GMP Principles.
5. Demonstrate Subject Matter Expertise (SME) in at least one QA System.
6. Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
7. Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self and any direct reports.
8. Represent own and direct reports work on quality records (Change controls, Batch Manufacturing Record, validation documentation etc.) in customer and regulatory audits.
9. Where appropriately trained be able to deputise for and carry out the duties of nominated QA personnel of similar grade.



1. Minimum of two A level(s) in science based subjects or similar qualification or equivalent competence demonstrated by experience in a GMP environment.
2. Knowledge of how the principles and practices of GMP are applied to the manufacture of biologics, including competence in impact assessment.
3. It is essential that the job holder is a self starter, able to work without supervision and manage conflicting priorities but still deliver high quality work.

QA Manufacturing:
1. To act as the QA Representative on Business Programmes, involved in the manufacture of biological Bulk Drug Substance (BDS) and cell banks used in clinical trials and commercial product. Responsible for up to 10 programmes per annum, acting as the main customer interface for all Quality related aspects of a programme.
2. Build and maintain good working relationships with Manufacturing. Work with manufacturing personnel to improve compliance and feedback learning. Act as the primary QA representative during manufacture.
3. Co-ordinate batch disposition activities
4. Responsible for the review of customers regulatory submissions including the data to support these submissions.
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