The Quality Engineer Analyst will work closely with our operational and quality teams to support investigation of events, identification of root cause, definition and implementation of CAPA plans and monitoring of their effectiveness.
You will be responsible for co-ordinating and driving completion of all quality records in a timely manner.
You will also be responsible for generating and analysing UK quality metrics as an input to Quality Management Review and training personnel in areas of expertise including event/CAPA management, risk analysis and data integrity.
There will be an element of direct client interaction and infrequent travel to other sites will also form part of this role.
Who you are:
Minimum Batchelor degree in relevant scientific or technical field
Significant experience in Quality Assurance or related field within a GMP environment
Experience with Manufacturing, food and Biological testing
Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, 21CFR Part 11, Data Integrity)
Advanced working knowledge of good documentation practices
Strong oral, written and interpersonal communication skills
Experience in leading root cause analysis investigations
Experience in defining CAPA plans and co-ordinating implementation
Experience in the application of quality risk management principles e.g. FMEA
Capable of making quality related decisions and providing guidance in areas of expertise
Experience leading and working in cross-functional teams
Proven record of achieving results within established timelines
Job Requisition ID: 204380
Career Level: D - Professional (4-9 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.