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Senior Quality Documentation Specialist - 2406210329W

Description

Johnson and Johnson is recruiting for a Senior Quality Documentation Specialist. The location for the position is Lexington, MA. It is part of the global PC&D Team. The position reports to the Director, in Lexington, MA (US).

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/.

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 worlds most pressing healthcare challenges.

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.

The Senior Quality Documentation Specialist will be responsible for the submission and approval of R&D documentation into the document control system, as well as the creation and execution of change control records in J&Js change management platform. This position supports all programs of the R&D group performing high level research and development supporting the implementation of new and existing technologies and processes. The Senior Quality Documentation Specialist will:

• Work closely with the R&D groups engineers and various JSC and DPDS departments (e.g. MSAT, AD, ESI, PES, etc.) to coordinate documentation implementation and change control activities.

• Coordinate documentation-related activities within the engineering R&D group.

• Maintain relationship with document control group and act as point of contact to obtain additional support when needed.

• Ensure correct and timely implementation of engineering documents into Janssens document control system.

o Documents include: Process documents, engineering drawings, specifications, and various reports

• Coordinate and document change control activities within the engineering R&D group

• Act as change control champion for the R&D group, cross-functionally driving on-time creation, execution and closure of change control deliverables.

• Perform data integrity review of documents stemming from R&D to ensure accuracy and integrity of reported data.

• Work with some supervision to ensure near-term and long-term organizational outcomes are achieved.

• Receive direction from management, but is typically responsible for execution which directly impacts the goals and objectives of the specific program.

• Communicate internally to functional and project teams as needed to maintain committed timelines and deliverables.

• Act as liaison with document control group and change control teams.

• Ensure that all necessary procedures are followed to successfully implement documentation and change control processes for the R&D group.

• Ensure team awareness and compliance with processes through weekly meetings and direct communication with responsible project engineers.

• Lead group-wide meetings to ensure that high volume of documentation and changes are appropriately prioritized to meet project deadlines.

Qualifications

Qualifications:

• B.S. degree in an appropriate discipline with 5-6 years experience or MS/MBA/PhD with 1-2 Years experience required

• Pharmaceutical or Medical Device industry experience preferred

• Project management experience

• Experience with document control solutions

• Experience working in regulated environment with GxP requirements

• Computer skills (MS Office)

• Good organizing, planning and problem solving skills

• Able to interface effectively with people of various groups and discipline

• Customer oriented approach to problem solving

• Set priorities and meet deadlines

• Self-starter able to work and/or manage people in a matrixed environment

• Ability to motivate others to get the job done effectively and in a timely manner

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.

Primary Location NA-US-Massachusetts-Lexington

Organization Janssen Research & Development, LLC (6084)

Job Function Quality Documentation

Req ID: 2406210329W