A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Responsible for maintaining the archives infrastructure as per applicable GxP regulatory requirements [i.e., Good Laboratory Practice (21 CFR Part 58) and current Good Manufacturing Practice (21 CFR Part 210 and 211)]. Responsible for management of the document retention and retrieval processes.
- Implement and maintain orderly storage of documentation (i.e., raw data, protocols, final reports, etc.) and specimens in adherence to policies and procedures for archiving and retention of documents / specimens generated in support of GxP regulated activities
- Manage retention of documents / specimens in the archives and assure appropriate indexing to permit expedient retrieval
- Manage access to on-site and off-site archive locations
- Provide oversight of off-site archive vendors including audits and management of invoices
- Track location of documents / specimens retained with off-site vendor and ensure conditions of storage minimize deterioration
- Provide training on archive related tasks and assist with supervision of archives personnel
- Participate in client audits, internal audits, and GxP regulatory inspections.
- Interface with laboratory systems' owners to ensure appropriate archival of electronic data
- Collaborate with global quality teams to implement and maintain archive processes and systems
- Bachelor's degree in a scientific (i.e. Biology, Chemistry, etc.) or a technical (Biotechnology, Biochemistry, etc.) discipline
- 4+ years' experience in Quality Assurance or related field within a GxP environment
- Acts ethically and ensures quality of own work and that of others
- Collaborates with various teams to identify and implement improvements
- Applies technology to drive digitalization and improve quality and increase customer value
- Works with agility
- Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
- Excellent written and verbal communication skills
- Excellent organizational skills
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil 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 https://jobs.vibrantm.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 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.
Job Requisition ID: 213902
Career Level: C - Professional (1-3 years)
Working time model: full-time
This job has expired.