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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

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

San Angelo, Texas, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Quality Control Supervisor to be in San Angelo, TX.

The Quality Control Supervisor is responsible for managing and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products in order to ensure compliance with quality standards and production schedules. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, teams among other tasks.

You will be responsible for :

• Responsible for communicating business related issues or opportunities to next management level.

• Approve instrument qualification(s), method validation(s) and method transfer protocol(s), change project(s), change order(s) and all other change management items required

• Writes Audit Observations or CAPA action plans and/or effectiveness monitoring plans

• Write Failure Investigations to support ETQ nonconformances and/or provided support to product disposition

• Communicates department objectives and metrics.

• Operating in compliance within current GMPs. This includes the ability to understand, write and apply SOPs to meet GMP requirements for documenting, testing and maintaining accurate laboratory records

• Working closely with R&D in support of development, troubleshooting, validation and transfer of test methods to a commercial QA/QC laboratory.

• Preparing instrument qualification, method validation and method transfer protocols, execution of protocols and preparation and submission of reports for review and approval.

• Supporting Laboratory Instrument/Software Lifecycle Management

• Initiating and investigating non-conforming laboratory test results as well as potentially escalating stability alerts and quality issues to management.

• Using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency.

• Developing, writing, updating, reviewing & implementation of test methods, SOPs, protocols and specifications as required.

• Providing training for others on test methods, protocols, specifications, laboratory core competencies and SOPs

• Providing audit support (e.g. front room, back room or SME).

• Working with cross functional teams to successfully resolve audit findings, product non­ conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design.

• Independently leading large projects as wells as facilitating projects according to priorities and providing periodic updates to management

• Providing innovative approaches to solving technical problems and troubleshooting with limited guidance from management or other scientific personnel while maintaining a high level of cGMP awareness.

• Maintaining up to date knowledge of the company's products and manufacturing processes related to relevant laboratory testing.

• Working independently on complex issues and developing solutions to problems of moderate scope and complexity to draw valid conclusions

• Performing in a leadership role (team leader on intra and inter-departmental teams

• Initial and final review of data generated by peers and contract laboratories.

• Assisting in various other duties which contribute to the organization and function of the laboratory (e.g. laboratory inventory process).

• Act as BOP Walkthrough Lead/Designee for the Site Management Team.

• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001

Qualifications/Requirements:

• A minimum of a bachelor’s degree is required

• A minimum of 2 years of work experience within a similar manufacturing setting and/or performed supervisor duties in a Manufacturing or Lab setting is required.

• Ability to use Laboratory Software Applications such as Chromatographic Data Systems, Laboratory Execution Systems and Laboratory Information Management Systems.

• Ability to work independently

• Good interpersonal, organizational and oral and written communication skills

• Must be able to interact well with peers and colleagues

• This position will be required to report to work fully onsite at San Angelo, TX

• The Manufacturing site is a 24/7 operation; weekends and holidays are included in the work schedule. This position will have a rotative schedule.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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