A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Quality Assurance Specialist role will support activities in the Quality Management Systems group at a site manufacturing custom Active Pharmaceutical Ingredients (API) in accordance to ICH Q7, 21 CFR Part 11, Eudralex Volume 4, EU Annex chapters, various compendia, and other cGMP regulations as applicable. In support of site wide objectives this role will assist with communication, scheduling, resources, execution, response, close out, tracking, and metrics of all audits and inspections.
Responsibilities associated with this role include assisting with quality systems and quality operations such as Internal and external audit management, change management, validation, complaint management, applications, training, and deviation/CAPA management.
This role will work with the procurement, manufacturing, technical operations, validation, process & analytical development, quality control, packaging, materials management, engineering, and maintenance groups in support of client audits, regulatory inspections, internal self-inspections, internal divisional audits, and the supplier qualification program.
Who you are:
- B.S./B.A. in the Life Sciences, Chemistry, or Chemical Engineering with 3+ years of experience in a GMP or API environment -OR- a B.S./B.A. in a non-science discipline with 10+ years of Quality System, GMP or API environments, experience in validation.
- 3+ years of experience with GMP guidelines for the pharmaceutical industry to include ICH Q7, 21 CFR Part 11, Eudralex Volume 4, and EU Annex chapters.
- Good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software.
- Data analysis, presentation, and experimental design knowledge desired.
- Excellent communication (verbal & written) and customer interface skills.
- Excellent writing skills and experience writing technical documentation & reports.
- Ability to simultaneously manage multiple tasks/priorities.
- Good problem-solving skills/abilities.
- Good time management and negotiating skills.
- Capacity for independent work.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.