SRG - QA Specialist - Clinical

Bionow; Greater Manchester; On-site; GBP 41,000; Full time

Job summary

An innovative life sciences company in Greater Manchester is seeking a QA Officer to oversee quality and compliance for clinical activities. The role includes international travel and offers a salary of £41,000. Candidates should have a degree and proven GCP experience, along with knowledge of relevant regulations.

Qualifications

• Degree or similar qualification in a relevant subject or equivalent experience.
• Proven experience in GCP environment.
• Knowledge of In-Vitro Diagnostic or Medical Device Regulations is advantageous.

Responsibilities

• Ensure compliance during trial activities.
• Represent Clinical QA in clinical trials.
• Support qualification and perform independent QA audits.

Skills

GCP experience

Knowledge of regulations

Audit experience

Familiarity with regulatory inspections

Education

Degree or qualification in relevant subject

Job description

Title: QA Officer - Clinical
Location: Greater Manchester
Salary: £41,000

About the Role

SRG is recruiting for a QA Officer with GCP experience to join an innovative company whose technologies are integral to the advancement of life science and healthcare research worldwide.

Based at their site in Greater Manchester, you will oversee quality and compliance of clinical activities supporting the testing and registration of diagnostic tests across global trials. The role involves international travel to sites across Europe and the USA.

Key Responsibilities:

1. Work with the Clinical Affairs team to ensure compliance during trial activities (e.g., closure of deviations, handling complaints).
2. Represent Clinical QA in planned and ongoing clinical trials, including reviewing clinically relevant documentation.
3. Support qualification and perform independent QA audits of clinical study sites.
4. Participate in the internal audit program.
5. Review Clinical Affairs SOPs.

What We're Looking For:

1. A degree or similar qualification in a relevant subject or equivalent experience.
2. Proven experience in a GCP environment with knowledge of relevant regulations, standards, guidelines, and best practices.
3. Knowledge of In-Vitro Diagnostic or Medical Device Regulations is advantageous.
4. Audit experience and familiarity with regulatory inspections are desirable.
5. Willingness and ability to travel internationally (Europe and USA).

Bionow is an award-winning business development and services company serving the life science sector in Northern England. We support business growth, innovation, and competitiveness through specialist services, guidance, networking events, and membership benefits. We welcome inquiries from current and potential members.