job Profile: Document Control Process Owner
Company Name: Danaher
Danaher
• Pensacola, FL, United States
• via Danaher – Danaher Corporation
Full–time
Job highlights
Identified by Google from the original job post
Qualifications
- Strong foundational knowledge in current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP)
- Highly skilled in Microsoft Word for comparing and merging documents, creating and using templates, creating form using fields and using advance formatting built in styles
- Strong interpersonal and communications skills
- Technical Writing
- Experience with Veeva & Magic systems
Benefits of Danaher
- The salary range for this role is $65,000-82,000
- This job is also eligible for bonus/incentive pay
- We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees
- Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable
- The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law
Responsibilities
- The Document Control Process Owner for Cytiva is responsible for the administration of documents in the electronic QMS and PLM systems
- Performs evaluation of internal controls, and maintenance of documentation as related to compliance with internal and external quality and regulatory standards
- Assist with the implementation of standard operating procedures to define and improve quality system functions
- Collaborate with cross-functional teams (internal and external) to establish and maintain document controls that align with applicable regulatory requirements
- Ensure compliance with documentation requirements defined in ISO 9001, ISO 14000and OSHA PSM and other international guidelines as appropriate
- Ensure compliance throughout the document/record lifecycle: including the creation, approval, issuance, revision, retention, timely retrieval during audits, and obsoletion
- Provide oversight of the document periodic review program, ensure status is conveyed to internal stakeholders and monitors related KPI
- Support the Document Control Review by tracking requested revisions and ensuring internal teams are apprised of changes and that implementation dates are met
- Proactively identify opportunities for process improvements, automation, and efficiency gains in the document control function
Job description for Danaher
Take part in something completely transformative!
Being at the vanguard of developing novel approaches to improve human health is what it means to work at Cytiva. Our amazing clients work on projects that have the potential to save lives, from basic biology research to the creation of novel vaccines, medications, and cell and gene treatments.
You will be able to constantly better both yourself and us at Cytiva by working on important challenges with people who genuinely care about each other, our clients, and their patients. With associates in more than 40 countries, Cytiva is a place where learning opportunities abound every day, enabling you to advance your career and broaden your skill set over time.
We combine committed technological know-how and talent to create the next wave of game-changing medicines as a part of Danaher’s Biotechnology division.
The management of documents in the electronic PLM and QMS systems is the responsibility of the Document Control Process Owner for Cytiva. evaluates internal controls and keeps records up to date in relation to adhering to external and internal quality and regulatory standards. Support the establishment of standard operating procedures to specify and enhance high-quality system functionalities.
This job will be on-site and is a part of the Pensacola, Florida-based Quality Assurance Department. Our goal at Cytiva is to progress future treatments from research to delivery.
In this role, you will have the opportunity to:
• Collaborate with cross-functional teams (internal and external) to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in ISO 9001, ISO 14000and OSHA PSM and other international guidelines as appropriate.
• Ensure compliance throughout the document/record lifecycle: including the creation, approval, issuance, revision, retention, timely retrieval during audits, and obsoletion.
• Provide oversight of the document periodic review program, ensure status is conveyed to internal stakeholders and monitors related KPI.
• Support the Document Control Review by tracking requested revisions and ensuring internal teams are apprised of changes and that implementation dates are met.
• Proactively identify opportunities for process improvements, automation, and efficiency gains in the document control function.
The essential requirements of the job include:
• Bachelor’s Degree required; life science related field, preferred with 3+ years, or AA degree with 5+ years of relevant experience in document control/record control
• Experience with document control management and product lifecycle management systems, in biotech, pharma, drug product, or medical device document control experience preferred
• Strong foundational knowledge in current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP)
• Highly skilled in Microsoft Word for comparing and merging documents, creating and using templates, creating form using fields and using advance formatting built in styles.
It would be a plus if you also possess previous experience in:
• Strong interpersonal and communications skills.
• Technical Writing
• Experience with Veeva & Magic systems
The salary range for this role is $65,000-82,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
