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Quality Lead Specialist IV (1 of 2 positions).

Company: Johnson & Johnson
Location: Draper
Posted on: January 15, 2022

Job Description:

Zarbee's Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Specialist IV to support the Quality and Compliance Quality Assurance (QA) group to be based in Draper, UT!

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Johnson & Johnson Consumer Inc., is one of the world's largest consumer health and personal care products companies. We produce many trusted brands including JOHNSON'S - Baby, BAND-AID -, NEUTROGENA -, TYLENOL -, MOTRIN -, LISTERINE - and ZARBEE'S -. Each one of our consumer businesses embraces innovative science to develop products that anticipate consumer needs that help them live healthy, vibrant lives.

The Zarbees External Manufacturing Quality Lead position provides overall Quality Assurance Leadership in the management of contract manufacturing sites engaged in the production of oral ingestible and topical Dietary and Nutritional products for the Zarbee's Business Unit of J&J Consumer Sector ensuring compliance to 21CFR111 and 21CFR117.

The external Manufacturing Quality Lead is responsible for supporting Contract Manufacturing sites, driving compliance & quality improvement initiatives, assisting resolution of process/product non-conformance events, monitoring/resolving complaints, reviewing Annual Drug Product Review reports, reporting Contract Manufacturer performance metrics, interfacing with Zarbee's and J&J business partners and providing batch record release when required. This position may represent QA on projects and improvement teams by guiding and setting quality/compliance requirements, development of SOPs & specifications, and providing technical transfer/validation support. This individual will comply with Federal and worldwide regulations and meets the needs of the business and supply chain.

Key Responsibilities
Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. A mentor to junior staff.
Provides overview or detailed communications to Q&C and cross-functional leadership on status of key initiatives and issues.
Document rationales which are technically accurate and regulatory compliance focused for product disposition, risk assessment/mitigation, non-conformances, corrective actions, and audit observation responses. Hold business partners accountable for delivering documentation of similar quality.
Conduct, execute and document thorough investigations and CAPAs for high risk/high complexity issues.
Ensure timeliness of deliverables through independent, proactive intervention. May act as a CAPA owner or be assigned as QA lead resource for a CAPA.
Troubleshoot high risk/high complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.
Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects.
Represent NA Source Quality on multiple, simultaneous, high-impact/ high-value projects as the "Voice of Quality", including active team engagement, proactively ensuring quality and compliance inputs are
Integrated into the project objectives, and act as a QA "go-to" resource for cross-functional business partners
Is accountable to deliver a set of metrics for safety, quality and customer service that map to the plant objectives.
Ensures that individual and team goals are aligned.
Independently manage and prioritize highly complex and diverse workload ensuring deliverables are on-time, accurate, and meet their intended objective.
Independent decision-making authority and accountability for product disposition and compliance decisions with significant potential impact to customer service.
Review and approve compliance records, specifications, development plans, procedures, and other documents, as required by procedure.
Leads the development and introduction of new processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.
Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions and recommendations in case of QRB and Escalations.
Drive closure of MAPs, through holistic and comprehensive engagement and negotiation with EM.

Essential Functions Define key accountabilities and/or activities. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. % OF TIME Investigations (J&J and manufacturing site), CAPA's and quality/compliance issues.
Troubleshoot high risk/high complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes 30 - 50%
APR/GCC Project initiatives - Validation Protocols, Validation Reports, Specification approvals, etc.
Review and approve compliance records, specifications, batch records, change controls, procedures, and other documents, as required by procedure 20 - 40%
Key quality & compliance improvement initiatives at contract manufacturing sites such as:
Electronic Label mix-up prevention, Electronic pre-weigh systems, robust product release systems, implementation of WWSP/QSP/SOP requirements, etc. 10 - 15%
Review Annual Drug Product reports 0 - 10%
Support established contract manufacturing sites via, developing contract site MAP (Management Action Plan) to address identified gaps and ensuring resolution of MAP items. 10 - 15%
Collecting and reporting of monthly and quarterly metrics to management 0 - 5%
Training 5 - 10%

Qualifications

Required Qualifications
A minimum of a Bachelor's Degree (BA/BS)
A minimum of 6-8 years of GMP experience (or 4-6 years of experience in a QA role, with plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production
Strong communication (verbal & written) and interpersonal skills, self-awareness and adaptability
Experience and demonstrated skills in navigating in a matrix environment, managing complexity, collaborating across boundaries and influencing without authority
Have the ability to travel to external manufacturing sites

Preferred Qualifications
Master's degree
A focused degree in Engineering, Chemistry, Biology, or Biological Sciences
QA/QC previous experience will be valuable
Understanding manufacturing processes is an asset

Knowledge, Skills And Abilities
Proven ability to lead and influence others within product teams with excellent communication and presentation skills.
Detail-oriented, with the ability to work in a fast paced environment with multiple, concurrent priorities many needing immediate resolution.

Certification/Licenses: Not required

Location of Role: Salt Lake City/Draper, UT

Language Requirements: English

Travel Requirements: up to 10%

Environmental Requirements: Defined in local SOPs

Physical/Work Requirements: N/A

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

United States-Utah-Draper-Zarbee's

Other Locations

North America-Canada

Organization

Zarbees (6263)

Job Function

Quality

Requisition ID

2105991733W

Keywords: Johnson & Johnson, Draper , Quality Lead Specialist IV (1 of 2 positions)., Other , Draper, Utah

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