Lead Specialist QA Investigations

Sonara Inc.; St Albans; On-site; GBP 49,000 - 95,000; Full time

Job summary

A leading global healthcare company is seeking a Lead Specialist QA Investigations in St Albans, England. The ideal candidate will lead critical investigations, mentor QA teams, and analyze data to support quality improvement initiatives. Minimum qualifications include a Bachelor's degree and 4-7 years of experience, with a strong understanding of cGMP and quality systems. This role offers a competitive salary ranging from $66,000 to $127,000, along with benefits in an inclusive environment.

Benefits

Competitive salary

Benefits

Inclusive environment

Qualifications

• 4-7 years of experience in a relevant field.
• Experience with cGMP standards and investigation reports.
• Ability to perform advanced mathematical calculations.

Responsibilities

• Lead investigations of incidents and issues.
• Mentor and support training for QA Specialist Investigators.
• Analyze investigation information for reports and presentations.
• Lead continuous improvement projects and CAPA executions.

Skills

cGMP knowledge

Quality Systems

Root cause analysis

Statistical analysis

Technical writing

Strong communication skills

Education

Bachelor's degree or equivalent

Job description

Mylan Technologies, Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access- Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership- Advancing sustainable operations and innovative solutions to improve patient health; and
• Partnership- Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Lead Specialist QA Investigations role will make an impact:

Key responsibilities for this role include:

• Lead critical / complex investigations of incidents, issues, and trends. Leads / facilitates cross functional structured problem solving in support of investigations. Propose associated CAPA actions and prepare associated investigation reports.
• Lead / participate in the triage of deviations, assuring appropriate initial evaluation of extent/scope and containment actions occur to minimize risk and potential product/quality impact.
• Provides mentorship and supports training/development of QA Specialist Investigators.
• Compile and analyze investigation information required for Annual Product Reviews, Management Review, Site Metrics, and other business needs, and prepare associated reports and/or presentation slides. Present to local and vertical leadership as required. Prepare and/or approve associated reports.
• Performs review/close out and effectiveness checks of completed CAPA, in accordance with the approved CAPA.
• Leads periodic and special cause trending assessments to determine corrective actions to address trends. Prepare periodic reports as assigned.
• Leads continuous improvement project teams, as well as owns and executes department CAPA as assigned. Develops strategies and tactics for accomplishing objectives, manages tasks execution through completion.
• Authors new or revised site procedures as assigned. Prepares and provides training related to investigations, site procedures and cGMP as assigned
• Approves laboratory investigations, incidents, and investigations as authorized.

The minimum qualifications for this role are:

• Minimum of a Bachelor's degree (or equivalent) and 4-7 years of experience. However, a combination of experience and/or education will be taken into consideration.
• Must possess a working knowledge of cGMP, Quality Systems, and root cause analysis techniques. Must understand the cGMP standards for the investigation of non-conformances and the contents of investigation reports.
• Ability to add, subtract, multiply and divide. Statistical Analysis, Advanced Mathematical calculations.
• Must possess strong communication skills (written and verbal). Must have experience in technical writing.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is: $66,000 - $127,000.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.