A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 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. EMD Performance Materials is a business of Merck KGaA, Darmstadt, Germany.
The Document Control Specialist is responsible for maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and standards.
- Responsible for reviewing Document Change Controls to ensure proper revision control records.
- Ensure documentation is processed, formatted, issued, and made effective accurately.
- Participate in improvement projects and be able to conduct CAPA investigation on any audit findings or CAPA events.
- Involve in label and marketing review.
- Audit changes for accuracy and completion.
- Assist in the document periodic review process.
- Provide guidance and communication to Originators in order to share best practices and resolve change issues and/or discrepancies.
- Provide document control system and change procedure training support as needed to co-workers within and outside Document Control.
- Promptly respond to questions and issues raised by Originators and Approvers.
- Work with Originators in following-up, analyzing and helping to resolve open change control issues. Work with management to ensure training curriculum are up to date.
- Responsible for reviewing and processing labeling including IFUs. Ensuring label verification and IFU reviews are completed in a timely manner.
- Lead/participate in projects/assignments that support continuous improvement efforts and department/company goals.
- Perform other projects related to improvement of quality systems as needed and required by management.
- Additional responsibilities may be assigned by Supervisor or Manager as needed to support the Organization.
General Responsibilities and Authority:
- Understands, supports, and communicates Company mission, vision, and values.
- Understands and follows the requirements of the quality system.
- Initiate actions as necessary to prevent occurrence of any non-conformance related to the product, process, or the quality system.
- Identify and document any problems related to product, process, or the quality system.
- Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
Who You Are:
- Bachelor’s degree in a Scientific related field or High School Diploma, GED or Associates and 5yrs experience within doc control in a ISO 13485 environment.
- 2+ years of experience in document control in biotech or related regulated industry.
- 2+ years of experience in a GMP environment.
- 2+ years’ experience with Microsoft Office Suite (Word, SharePoint, Excel, Outlook, etc.) and Adobe.
- 4+ years of experience in FDA QSRs cGMP, and ISO 13485 or other related industry standards is highly preferred.
- Experience with Document Management systems, preferably ManGo and/or Doc Compliance (eDoc) System preferred.
- Experience with Trackwise and SAP NEXT preferred.
- Excellent organizational, interpersonal, and communications (written and verbal) skills.
- Must exhibit professional behavior and appearance and be aware of the importance of teamwork within the assigned department.
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.