Job Profile: Document Control Process Owner
Company Name: Danaher
Danaher
• Pensacola, FL, United States
• via Danaher – Danaher Corporation
26 days ago
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 management of documents in the electronic QMS and PLM 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.
- Work together with internal and external cross-functional teams to create and manage document controls that comply with relevant regulatory standards.
- Make sure that the documentation standards outlined in ISO 9001, ISO 14000, OSHA PSM, and other international criteria are followed, if applicable.
- Make that all phases of the document/record lifecycle are compliant, including creation, approval, issuance, amendment, retention, prompt retrieval during audits, and obsolescence.
- oversee the program for periodic examination of documents and make sure that its state is
- 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
Be part of something altogether life-changing!
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 position is part of the Quality Assurance Department located in Pensacola, Florida and will be on-site, At Cytiva, our vision is, to advance future therapeutics from discovery 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.
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 pharmaceuticals from discovery to market release.
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
This position pays between $65,000 and $82,000. At the time of this posting, we believed that this was the range of possible remuneration for this function, and we still do. In the end, we might pay more or less than the indicated range. There could be future changes to this range.
Bonus and incentive money are also available for this position.
For qualified staff, we provide a full range of benefits, such as paid time off, health, dental, and vision insurance, as well as a 401(k).
Note: Until a sum of money is earned, vested, and determinable, it is not regarded as wages or compensation. The quantity and accessibility of any commissions, bonuses, benefits, or other types of pay 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 combine science, technology, and operational skills to expedite the use of science and technology of tomorrow in practical applications. We collaborate with clients all over the world to help them overcome their most difficult problems by designing solutions that truly harness the power of science. Our international teams are setting the standard in the fields of biotechnology, diagnostics, life sciences, and other fields. To learn more, go to www.danaher.com.
Regardless of race, color, national origin, religion, sex, age, marital status, handicap, veteran status, sexual orientation, gender identity, or other legally protected characteristics, Danaher Corporation and all Danaher Companies are dedicated to equal opportunity. We place a high importance on diversity and the presence of both obvious and hidden similarities and differences in our employees, our workplace, and the markets we service. 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.
