27 days old

Quality Specialist

Kelly Services
Skillman, NJ 08558
Kelly Outsourcing Consulting Group, KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Quality Specialist for a long-term engagement at one of our Global clients in Skillman, NJ. This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You ll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.


The Quality Specialist will be responsible for complying with processes and controls ensuring that the performance and quality of new products conform to established standards and are in compliance with Global and Regional policies and procedures, U.S. and Global Quality System Regulations (QSRs) including 21 CFR 210 & 211, 21 CFR 820 and 21 CFR Part 11 and current Good Manufacturing Practices. The products managed include multiple regulatory classifications (Cosmetics, OTCs, NDAs, Class I and II Medical Devices, and Combination Products). This individual will ensure cross-functional partners understand our quality system requirements and how they impact product quality and regulatory compliance. He/she will be an integral member of project teams to ensure compliance and quality requirements are met during product development, scale up and validation.


+ Represent Quality Assurance function on multiple, simultaneous, high-impact/high-value projects as the Voice of Quality, including active team engagement, proactively ensuring that quality and compliance inputs are integrated into project objectives, and act as a QA go-to resource for cross-functional business partners.

+ Assume full QA oversight responsibility for high-complexity and/or high-risk new product introduction projects across multiple product, regulatory, and/or technology types.

+ Partner with Technical Transfer / Support to Marketed Product teams to coordinate new product development and launch requirements, including validation and stability requirements in support of commercialization and documentation readiness.

+ Independently manage and prioritize highly complex and diverse workload, ensuring that deliverables are on- time, accurate, and meet their intended objective.

+ Review and approve compliance records, specifications, new product introduction development plans, procedures, and other documents with significant regulatory compliance impact.

+ Proactively participate on new product development teams, including the selection and qualification of new sites and execution of project deliverables.

+ Hold business partners accountable for meeting project development plan requirements, and independently drive timely completion of validation activities at external sites.

+ Troubleshoot high-risk/high-complexity quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.

+ Independently interact with senior Quality leadership to negotiate and influence quality decisions.

+ Develop and deliver all QA clearance statements Right First Time for APR approval.

+ Subject Matter Expert (SME) for quality assurance processes, procedures, audits (internal and external), and activities. Develop and deliver training on QA-related topics. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. A mentor to junior staff.

+ Provide detailed or summary communication to QA and cross-functional management on status of key initiatives and issues.



+ A minimum of a Bachelors Degree is required.

+ A focused degree in a technical field (Engineering, Sciences, or similar disciplines) is preferred.


+ A minimum of 6 years of GMP experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug, Cosmetic, and/or Food and Dietary Supplements production (or a minimum of 4 years experience with an Advanced degree/MBA)

+ Experience in New Product Development Quality and Quality Systems is preferred. Experience in R&D, Process Development, Technical Transfer, Analytical Chemistry, Clinical Research, Microbiology or Product Safety is preferred. Experience with complaint vigilance and/or complaint reporting is preferred.

**Knowledge, Skills and Abilities:**

+ Detailed working knowledge of cGMP requirements and current FDA enforcement issues.

+ Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.

+ Demonstrated ability to work on complex or ambiguous issues autonomously, with little/no daily direction.

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position).

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-30 Expires: 2020-12-12

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Quality Specialist

Kelly Services
Skillman, NJ 08558

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