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  • Job reference: RMS0170236

QA Associate - Supplier Assurance

  • Sector: Engineering
  • Location: Billingham
  • Job type: Permanent
  • Date posted: 05/08/2016
  • Time left:
    d h m s
    (02/09/16)
This vacancy has now expired.
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:
To work within the Supplier Assurance Team as part of Quality Assurance. Duties will include, but are not exclusive to :

Reviewing specifications, assuring supply routes of materials consumables required for GMP and non- GMP manufacture at Billingham. Assess notifications of changes and potential to impact product quality. Leasing with various departments and teams across site to ensure milestones are met in a timely manner. Preparation and approval of required compliance documentation for batch disposition.

JOB PURPOSE:
To operate, administer, maintain, develop and continuously improve the routine systems operated by the QA Department 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.

Must be a flexible, self-starting team player, able to work with minimum supervision, who possesses good organisational, time management and interpersonal skills and is able to deliver high quality and accurate work.

Key Techniques:
• Principles and application of Good Manufacturing Practice (cGMP)
• Team work and good interpersonal skills
• Coaching
• Thoroughness
• Concern for Standards
• Tenacity
• Self-Development Orientation
• Analytical Thinking
• Ability to learn
• Critical Information Seeking

Accountabilities:
PRINCIPAL ACCOUNTABILITIES
1. Administer, maintain, and continuously improve any assigned QA systems, which may include, Document Control and Issue, Change Control, Events Deviations & Non Conformances (Trackwise) Root cause analysis, CAPA’s, Qualification and Validation, Materials Assurance, Auditing and Training.
2. Operate core QA events
3. Document writing and review processes as instructed by QA Management.
4. Ensure self has no overdue training, or site actions.
5. Train staff in own and other areas as required in specific tasks related to job role.
6. Ensure local work processes are continuously improved and any efficiency gains are captured in procedures.
7. Continuously improve the Safety, Health, and Environmental impacts of local work process operated by self and team.
8. Represent own work on quality records (Change controls, Batch Manufacturing Record, validation documentation etc.) in audits and inspections as required
9. Where appropriately trained be able to deputise for and carry out the duties of nominated QA personnel of similar grade.
10. Deputise for QA Associate Manager, when required.
11. Support staff, assist and advise where required.
12. Must be able to prioritise workload.
13. Support the site in the delivery of the site objectives.
14. Build and maintain good working relationships with relevant departments and personnel as required.
15. Support QA Manager in development and maintenance of systems within the QA department.
16. Actively participate in continuous improvement and self-development.

Essential Skills / Qualifications:
• Minimum of one A level in a science subjects or similar qualification or equivalent competence demonstrated by experience
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