Johnson & Johnson is currently seeking a Document Control Specialist in Santa Clara, CA.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Key Responsibilities:
- Facilitate the change control process from initiation through all workflows steps to implementation including review of completed change orders for content and the approvals.
- Collaborate and provide mentorship to change owners, approvers, and business partners.
- Review change orders and items for completeness and compliance with QSR, ISO and internal template and procedure requirements in a timely manner.
- Perform final incorporation of documentation revisions and pre-release preparation of the document files associated with approved change orders and ensure workflow activities are completed.
- Consult with end users regarding problems in accessing electronic content
- Select and/or verify required approvers of changes per procedures.
- Assist in the preparation of document control metrics and reports, including but not limited to periodic review process and change order timeliness
- Communicate the status of changes.
- Support and recommend change control process improvements including initiating procedural revisions.
- Support both internal and external audits, as well as quality events (CAPA, NC, Audit findings), relating to document/change control processes.
Qualifications
Education:
- Minimum of a Bachelor's, equivalent University Degree or equivalent experience in Document Control and Change Management in a design, development and manufacturing environment required
Experience and Skills:
Required:
- Minimum 2 years of relevant work experience
- Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint)
- Proven understanding of electronic documentation systems, data retrieval and electronic file formats
- Ability to collaborate in an open office environment and remotely with virtual teams while paying attention to detail
- Work successfully and in coordination with others and other departments in achieving organizational goals
- Ability to coordinate, prioritize, and balance multiple projects and tasks simultaneously
- Strong analytical, prioritization, communication, and leadership skills
- Proven experience/knowledge with managing parts/BOM structures/drawings
- Ability to work independently without supervision and in a team
- Prompt in reporting for work and effectively and efficiently uses their time to accomplish their job tasks
- Ability to meet project achievements and work in a fast-paced environment
Preferred:
- Experience with Product Lifecycle Management (PLM) systems, such as Agile PLM, ADAPTIV (Enovia platform), Windchill, and/or equivalent PLM systems within a regulated industry - Direct experience with Agile PLM is highly desired
- Familiarity and ability to apply Good Manufacturing Practices (GMPs) documentation requirements, especially pertaining to quality records and change control
- Medical Device, Pharmaceutical, and/or Biotech experience
- An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, and process control is preferred.
- Experience with MRP/ERP systems such as SAP
Other:
- This position is located in Santa Clara/San Jose, CA, and requires less than 10% domestic travel.
Additional Information:
The anticipated base pay range for this position is $76,000 to $121,900.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. •
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
There is a pre-identified candidate for consideration. However, all applications will still be reviewed.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.