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Johnson &
Johnson Services Inc, part of the Johnson & Johnson family of companies, is
currently recruiting a Senior Analyst TQ - Manufacturing Services/ Lab
Services. This position can sit anywhere in North America or Puerto Rico and
will be a remote opportunity.











Summary





Technology
Quality Computerized System Validation (Q-CSV) Center Of Excellence ensures
compliance of systems across the enterprise in accordance with J&J SDLC,
assures compliance within the enterprise with applicable global regulations,
advise on quality matters, and assist with closing compliance gaps related to
audits and inspections.











The Sr Analyst TQ
- Manufacturing/Lab Services is responsible for the following:







+ Reviewing and approving validation
deliverables of GxP regulated Computerized Systems to ensure full compliance
with Health Authority regulatory requirements and adherence to company policies
and procedures by supporting computer validation projects and base business
support teams



+ Supporting internal and external
Health Authority regulatory audits



+ Responsible for the review and
approval of SDLC validation documentation deliverables including the approval
to release system implementation and/or changes for production use



+ Attending Project Team meetings and
provide CSV compliance guidance and support to project and base business
support team members.



+ Lead/support validation efforts and
deliverables for projects requiring validation



+ Maintain and Report the project
related Metrics



+ Perform pre and post review and
approval of validation test scripts including test defects



+ Author, review, and/or approve of
validation documentation deliverables such as but not limited to Compliance
Plans, User Requirements, System Tests, User Acceptance Tests, Traceability
Matrix, and the Compliance Report including final release and approval for
production use



+ Perform CSV review and approval of
Computerized System change controls including final release approval for
production use



+ Ensure a high degree of Inspection
Readiness for Systems in TQ portfolio with the purpose of minimizing the risk
of inspection observations to Business systems/infrastructure within TQ
responsibility



+ Participate in audits, approves audit
non-conformity action plans and approve closure of internal audit findings



+ Demonstrates an understanding of many
relevant Quality and Compliance areas and their applications



+ Proactively monitors systems and
processes to ensure compliance with standard operating procedures, audit
compliance and industry best practices



+ Facilitate education and training to
the organization on CSV program procedures and controls



+ Work with various SMEs to obtain
needed information to complete above deliverables; Leads testing efforts by
managing pre/post approvals and associated discrepancies



+ Works collaboratively with project
teams to keep them informed of project status, including any barriers



+ Builds
and maintains trusting, collaborative relationships and partnerships with
internal and external stakeholders which help accomplish key business
objectives, and helps others to do the same



+ Utilizes
knowledge of relevant Quality and Compliance principles to recommend existing
solutions to organization's needs



+ Provide
an environment which encourages the company's credo and diversity of opinions
and thoughts



+ Ensure
timely completion of assigned training and expense reporting



+ Perform other work related duties as
assigned



+ Describe important tasks or duties,
not mentioned above, that are performed infrequently and are not critical to
accomplishing the essential functions of the job



+ Develop and maintain an effective
working partnership with senior management.



+ Collaborate with other leaders and
staff within TQ group to ensure each function is executed in an efficient
manner.



+ Ensure timely reports of status,
metrics and time sheets as required by the TQ organization



+ Ensure timely completion of assigned
training and expense reports


























































Qualifications





+ A Bachelor's degree in Computer
Science, Information Systems, Business Administration or other related field
required



+ A minimum of 3 years of progressive
experience in the pharmaceutical/med device/biotech industry, with direct experience
in Computerized System Validation activities is required



+ Experience in authoring or approving
validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans
and Reports is required



+ Strong QA analyst skills with
experience in Computerized System Validation in GxP environments in the
pharmaceutical industry required



+ Experience in Testing Management tools
like HPALM is required



+ Project Management skills is a plus



+ Must have the ability to make
decisions by seeking out and maintaining trusting and collaborative
relationships to meet business needs and demands



+ Must have the ability to work
effectively in a highly matrixed team environment



+ Working knowledge of PMO, SDLC, GAMP
5, and ITIL frameworks is highly desirable



+ Thorough knowledge of cGMP regulations
related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is
required



+ Validation experience with
implementing LMS systems and other systems like LIMS, CAPA, MES, PLM, SAP,
Complaints Handling, and Change Control



+ Working knowledge of Global
regulations like Annex 11 is preferred



+ Superior written and oral
communication and excellent Microsoft Office skills are required



+ Knowledge of SDLC Quality Management
process and Computerized System Validation principles a plus



+ Must have the ability to perform work
with a high degree of independence in terms of self-management of a large
variety of tasks and initiatives regarding Quality



+ Must have the ability to independently
determine and develop approach to solutions and may determine long-term
solution



+ Ability to manage multiple and
competing projects as required



+ Requires travel, up to 20%-30%
domestic










































Primary Location

United States-Colorado-Monument-

Other Locations

North America-United States, North America-United States-Puerto Rico

Organization

Johnson & Johnson Services Inc. (6090)

Job Function

Validation

Requisition ID

855#######

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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