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Senior Analyst, Quality Documentation - 2406186185W

Description

Biosense Webster is recruiting for a Senior Analyst, Quality Documentation to be located in Santa Rosa, CA.

The Senior Analyst, Quality Documentation is responsible for maintaining quality management system documentation that meets regulatory, quality and company requirements. This position will oversee the training program as well as the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, archival and obsolescence to ensure full compliance.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:

• Responsible for the document change management process, ensuring that company documents are routed, reviewed, approved, controlled, and implemented in accordance with established procedures.

• Process Document Change Requests (DCRs) and ensure that all comments/corrections submitted against a document are communicated and successfully resolved or work with the correct departments for resolution before document is published.

• Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures.

• Reviews, edits, and formats, controlled documents according to approved procedures and templates, monitors document status and approval notifications, distribution, and archiving.

• Maintains revision and approval status of all controlled documents.

• Create and maintain document approval matrix to be used as baseline for document approvals.

• Ensure the management of controlled documents are processed in a timely manner while safeguarding quality, accuracy and adherence to company and regulatory requirements.

• Collaborate with cross-functional departments to ensure timely implementation of document change requests and change control associated tasks.

• Ensure compliance with established document control and record retention procedures.

• Maintain the document control system, including formatting, numbering, record retention and change control.

• Maintain filing and archiving of paper and electronic records.

• Develop document templates, standards, and conventions.

• Responsible for issuing, completing, closing, and archiving controlled documentation (including lab notebooks, logs, forms, procedures, test me, specifications, batch documentation and labels and maintain issuance log).

• Assure applicable site personnel are adequately trained in the policies and procedures of the document control system.

• Oversee the training program and ensure compliance with regulations, procedures, and best industry practices.

• Partner with cross-functional department leads to create and maintain employee training plans.

• Support improvement initiatives to strengthen document management and employee training processes and systems.

• Support internal and external audit activities.

• Develop and report on KPIs / metrics for Document Control and Training programs.

Qualifications

Education:

• A minimum of a Bachelor's degree is required.

Experience and Skills:

Required:

• Minimum of 4 years of experience providing quality system documentation management in an FDA regulated environment, preferably medical device manufacturing.

• Knowledge of U.S. and International regulatory requirements (e.g. 21 CFR Parts, 11, 820 and ISO 13485).

• Experience supporting regulatory inspections.

• Experience using electronic Quality Management System solutions in a regulated environment.

• Strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem-solving skills.

• Ability to make decisions and recommendations related to the role.

• Excellent organizational skills with an ability to think proactively and prioritize work.

• Demonstrated experience with Microsoft Office suite and Adobe Acrobat.

Other:

• This position may require a 10% of domestic travel.

• This position requires to work full onsite in Santa Rosa, CA location.

The anticipated base pay range for this position is $90,000 to $144,900.

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)).

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

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on 05/10/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

Primary Location NA-US-California-Santa Rosa

Organization Biosense Webster Inc. (6010)

Travel Yes, 10 % of the Time

Job Function Quality Documentation

Req ID: 2406186185W