Associate, Quality and Technical Support – Parsippany NJ

Job Title: Quality System Lead – Validation & Compliance

Summary:

The Quality System Lead will be responsible for reviewing and overseeing various validation and qualification documentation, including but not limited to, Process Validation, Cleaning Validation, Computer Validation, Equipment/Utilities Qualification, Commissioning, and Method Validation. The role involves reviewing key documentation such as Validation Master Plans, protocols, reports, design qualifications, risk assessments, traceability matrices, user requirement specifications, software/hardware design specifications, factory acceptance testing, engineering studies, media fills, smoke studies, site acceptance testing, system component criticality reviews, and protocol deviations related to new products, equipment, and systems.

Additional responsibilities include but are not limited to:

• Quality review and approval of Change Controls, Investigations, and CAPAs.

• Preparation and review of Annual Product Reports (APRs).

• Participation in internal and external cGMP audits.

• Preparation, review, and approval of Standard Operating Procedures (SOPs).

Key Responsibilities:

• Provide QA oversight of commissioning, validation, and qualification activities. Take the lead in reviewing and managing commissioning, qualification, and validation documentation with minimal guidance from management.

• Oversee and manage the review of shutdown-related activities, ensuring compliance with relevant standards.

• Review and/or prepare Investigations and Corrective and Preventive Actions (CAPAs) related to equipment, instruments, facilities, cleaning, quality control (QC), and process non-conformances.

• Actively engage in and support internal and external cGMP audits related to the FPG site.

• Lead the preparation and review of SOPs related to quality systems, with final QA review of SOPs across multiple departments, including Production, Engineering, Facilities/Maintenance, Validation, Supply Chain, and QC.

• Prepare and review Change Controls related to equipment, utilities, QC microbiology, QC analytical, batch records, and process changes at the FPG site.

• Lead the preparation and review of Annual Product Reports for products manufactured at the FPG site.

• Review and evaluate complaints for products produced at the FPG site to ensure compliance and quality.

• Lead QA efforts for development projects such as new EBR and LIMS modules.

• Oversee the review and approval of analyses and products in LIMS for new packaging and manufacturing components (e.g., bulk/finished product cartons, inserts, labels).

• Prepare, review, and approve specifications for new packaging and manufacturing components.

• Prepare statistical data for monthly, quarterly, and annual Quality Review Metrics. Assist in the preparation of Quality Review Board presentations for senior management.

• Perform other duties as assigned by Quality management.

Requirements:

• Bachelor of Science degree in Natural Sciences, Engineering, or a related field from an accredited institution.

• A minimum of seven (7) years of experience in GMP Quality Assurance, Manufacturing, Technical Services, or Validation within the medical device, pharmaceutical, or biopharmaceutical industries.

• Direct working knowledge of quality systems such as Trackwise, LIMS, EBRs, Oracle, or similar platforms.

• At least five (5) years of hands-on experience in executing and reviewing documentation related to Process Validation, Cleaning Validation, Computer Validation, Equipment/Utilities Qualification, Commissioning, and Method Validation.

• Strong problem-solving skills with the ability to work independently and proactively address issues.

• Deep understanding of cGMP, 21 CFR 210/211, and other applicable regulations, standards, and guidelines.

• Demonstrated expertise in quality systems within the pharmaceutical/biopharmaceutical or medical device industries.

• Proficient in Microsoft Office Suite (Word, Excel, Access, PowerPoint) and Adobe Acrobat.

• Familiarity with industry-standard documentation, training, and investigation practices.

• Excellent verbal and written communication skills, with the ability to effectively communicate complex ideas and concepts.

• High attention to detail, especially when reviewing documentation for SOP format compliance and accurate data entry into databases.

• Ability to handle multiple tasks and projects simultaneously.

• Strong negotiation and influence skills to work effectively with key partners and suppliers.

• A results-driven mindset, with the ability to deliver on commitments.

Preferred Qualifications:

• Experience in the development of new EBR and LIMS modules.

• Advanced knowledge of statistical analysis for Quality Review Metrics.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.