General Quality Control Manager
| Posting date: | 29 April 2025 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | Competitive Remuneration Package |
| Hours: | Full time |
| Closing date: | 29 May 2025 |
| Location: | SR5 3XB & NE11 0SD |
| Remote working: | On-site only |
| Company: | Helena Laboratories (UK) Ltd |
| Job type: | Permanent |
| Job reference: |
Summary
Role Summary:
To manage the day-to-day activities of the various quality control and assay departments in respect of the routine testing, value assignment, review and authorisation of product release to the market while continuously monitoring product performance via external quality assessment and liaising where appropriate with internal departments to support investigations into any issues identified.
Main Duties and Responsibilities:
1. To plan and direct the assay / quality control resource to meet the required product release and EQA timelines and be proactive in identifying potential delays and implementation of mitigating actions.
2. To provide first line investigation of and corrective and preventative actions to ongoing product issues reported by QC or other relevant sources.
3. To review the output of the assay / quality control scientists for compliance with agreed specifications including implementing remedial actions where the output is not acceptable.
4. To present concise and accurate product / departmental updates to the management / executive board as required.
5. To lead cross departmental meetings ensuring agenda is followed and outcomes/responsibilities are appropriately recorded for technical regulatory purposes.
6. To develop and maintain a high level of specialist knowledge of the instrumentation used within all departments with respect to detailed mechanical / theoretical method of operation.
7. To develop, maintain and apply a high level of theoretical electrophoresis and haemostasis knowledge to support quality control activities.
8. To develop a high level of knowledge of the features and workflow of required software programs across the electrophoresis and haemostasis divisions.
9. To train departmental personnel on both practical and theoretical areas of expertise and ensure maintenance of up-to-date training files.
10. To maintain control of testing materials including appropriate stock control activities to ensure timely and appropriate testing.
11. To undertake required human resources tasks such as annual leave requests, routine personnel reviews / performance management reviews and interviews for new personnel.
12. To drive the maintenance and creation of documentation (both departmental and product specific) in line with regulatory and market expectations.
Key Skills Required:
1. Good Life Science background, preferably in the Medical Devices/IVD Industry
2. Good laboratory practice.
3. Quality Control experience, preferably in Medical Devices/IVD Industry
4. Sound knowledge/interest in Electrophoresis, Capillary Electrophoresis and Haemostasis.
5. Experience in raising/approving/actioning change requests and raising/actioning non-conformances and deviations
6. Ability to effectively manage a team of experienced personnel
7. Flexible with the willingness to go above and beyond
8. Competent in the use of the Internet and Microsoft Windows programs including Word, Excel Power Point, and other statistical analysis software.
9. Competent mathematician and statistician.
10. Able to work well within a team.
11. Good communicator.
12. Excellent time management and organisational skills.
13. Ability to priority plan.
14. Able to communicate well with all personnel within the company.
This vacancy is permanent, full time Monday to Friday (daytime hours) and based at our sites across Sunderland and Gateshead.
Salary: Competitive Remuneration Package (negotiable depending upon skills and experience)
Applications (including your current CV and covering letter) should be
e-mailed to personnel@helena-biosciences.com
www.helena-biosciences.com
Registered in England: 1796207
To manage the day-to-day activities of the various quality control and assay departments in respect of the routine testing, value assignment, review and authorisation of product release to the market while continuously monitoring product performance via external quality assessment and liaising where appropriate with internal departments to support investigations into any issues identified.
Main Duties and Responsibilities:
1. To plan and direct the assay / quality control resource to meet the required product release and EQA timelines and be proactive in identifying potential delays and implementation of mitigating actions.
2. To provide first line investigation of and corrective and preventative actions to ongoing product issues reported by QC or other relevant sources.
3. To review the output of the assay / quality control scientists for compliance with agreed specifications including implementing remedial actions where the output is not acceptable.
4. To present concise and accurate product / departmental updates to the management / executive board as required.
5. To lead cross departmental meetings ensuring agenda is followed and outcomes/responsibilities are appropriately recorded for technical regulatory purposes.
6. To develop and maintain a high level of specialist knowledge of the instrumentation used within all departments with respect to detailed mechanical / theoretical method of operation.
7. To develop, maintain and apply a high level of theoretical electrophoresis and haemostasis knowledge to support quality control activities.
8. To develop a high level of knowledge of the features and workflow of required software programs across the electrophoresis and haemostasis divisions.
9. To train departmental personnel on both practical and theoretical areas of expertise and ensure maintenance of up-to-date training files.
10. To maintain control of testing materials including appropriate stock control activities to ensure timely and appropriate testing.
11. To undertake required human resources tasks such as annual leave requests, routine personnel reviews / performance management reviews and interviews for new personnel.
12. To drive the maintenance and creation of documentation (both departmental and product specific) in line with regulatory and market expectations.
Key Skills Required:
1. Good Life Science background, preferably in the Medical Devices/IVD Industry
2. Good laboratory practice.
3. Quality Control experience, preferably in Medical Devices/IVD Industry
4. Sound knowledge/interest in Electrophoresis, Capillary Electrophoresis and Haemostasis.
5. Experience in raising/approving/actioning change requests and raising/actioning non-conformances and deviations
6. Ability to effectively manage a team of experienced personnel
7. Flexible with the willingness to go above and beyond
8. Competent in the use of the Internet and Microsoft Windows programs including Word, Excel Power Point, and other statistical analysis software.
9. Competent mathematician and statistician.
10. Able to work well within a team.
11. Good communicator.
12. Excellent time management and organisational skills.
13. Ability to priority plan.
14. Able to communicate well with all personnel within the company.
This vacancy is permanent, full time Monday to Friday (daytime hours) and based at our sites across Sunderland and Gateshead.
Salary: Competitive Remuneration Package (negotiable depending upon skills and experience)
Applications (including your current CV and covering letter) should be
e-mailed to personnel@helena-biosciences.com
www.helena-biosciences.com
Registered in England: 1796207