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 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.
The Technical Documentation Coordinator‘s primary responsibility includes direct oversight of manufacturing related technical documentation. The position will be responsible for mentoring manufacturing staff on the drafting of technical documents that are minor in scope/impact, reviewing/approving documents that are minor in scope/impact, and writing/leading manufacturing investigations that are major/critical in scope/impact. In addition, the role will be responsible for tracking progress on all manufacturing related technical documents to ensure on-time completion with the goal of reducing manufacturing downtime and increasing client satisfaction.
- Lead major/critical deviation, CAPA, and OOS investigations
- Review and approve minor deviation and CAPA investigations
- Track deviation/CAPA/change control/OOS progress for manufacturing to ensure on-time completion
- Track/coordinate completion of manufacturing documentation (MBR corrections, deviation reports, OOS reports, campaign summary reports, etc.) upon completion of batches
- Be a manufacturing SME for root cause analysis and mentor other manufacturing staff to develop their investigation skills
- Mentor chemists to develop their technical writing skills
- Write/review manufacturing related technical reports/documents
- Write/review change control requests/implementation documents
- Assist in the formulation and execution of internal and external audit finding corrective actions
- Lead/support process improvement initiatives for those relating to technical documentation
- Assist with implementation of site wide initiatives for those relating to technical documentation
- Write/review manufacturing related operating procedures
- Participate in customer audits as necessary
Who You Are:
- BS in Chemistry, Biochemistry, Chemical Engineering, or equivalent, but may substitute education for qualified field experience.
- 3+ years GMP documentation experience with a demonstrated expertise in root cause analysis and CAPA generation.
- Strong oral and superior written communication skills
- Ability to work independently and as part of a team
- Knowledge of SAFC capabilities and understanding of various divisions, departments, cGMP and other relevant quality systems with strong evidence of collaborating in a matrix environment
- Analytical mind set
- Thorough understanding of MS Office suite
- Experience with TrackWise or other document control system is preferred
- Strong root cause analysis skills
- Detail oriented, thorough review of work
- Strong 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.