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28 days old

Quality Assurance Specialist

Kelly Services
Shepherdsville, KY 40165
Kelly Services is currently seeking a Quality Assurance Specialist in Shepherdsville, KY to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Quality Assurance Specialist **includes:**



Job Description:

The LVDC Quality Specialist/Quality Engineer is a highly-visible, multi-functional, proactive site leader who is instrumental in maintaining he companys Quality System and completing QA activities critical to delivering safe and timely supply of life-saving products to the market.


The role also achieves the companys continuous improvement targets by lifting site compliance capabilities, simplifying Quality System business processes, representing the site on regional and global forums, continuous professional development, and driving GMP/Good Distribution Practice compliance performance forward.


This individual will execute routine QA responsibilities to support daily Operations / business targets by releasing products and resolving quality issues to ensure product quality, patient safety, site safety and site compliance.


The individual will actively develop and improve quality system processes, and quality performance at the local, regional, and global level.


The Quality Specialist IV/QE brings significant technical and pharmaceutical knowledge, critical/analytical thinking and problem-solving skills, excellent personal, professional and technical communication skills, and a desire to teach, mentor and share knowledge/learning to continuously build site capabilities and quality culture.


The role serves as site business process owner (BPO) for multiple Quality System elements, and includes the role of backup for the manager / Responsible Person for the site as defined by the EU.


Minimum Requirements:

BS Degree in Chemistry-, Microbiology-, or Engineering- or Science/Pharmaceutical field.

10 years experience in pharmaceutical GMP commercial operations

5+ years direct experience in implementing or managing pharmaceutical / biologics GMP commercial quality management systems and processes

Solid and broad understanding of key pharmaceutical GMP Quality Systems (e.g. Risk management, change control, facilities/equipment)

Strong technical / operations experience and aptitude

Knowledge and practical experience of risk management, problem solving, root cause analysis, concepts and methodologies

Practical knowledge of federal and international pharmaceutical regulations

Data analysis, data verification, and problem-solving abilities.

Effective project management skills and/or substantial exposure to project-based work structures.

Proficient in MS Word, Excel, PowerPoint, Visio, Project


Preferred Background:

15+ years pharmaceutical / GMP commercial operations

Professional Certifications in Compliance, Quality Management, Quality Engineering, or Lean Six Sigma.

Knowledge of pharmaceutical distribution


Job Responsibilities:

Serving as local business process owner (BPO) for several of the companys quality system elements (e.g. change control, investigations, complaints, self-inspection, supplier quality management, etc.) to ensure their compliant and timely execution and continuous improvement.

Ensuring site operations, equipment, processes and product comply with local, regional, and corporate procedures

Maintaining controlled material status and distribution authorizations to ensure timely supply availability for distribution operations

Collecting, analyzing and reporting site Quality System metrics for the site leadership team to ensure effective Quality System monitoring.

Confirming technical quality and compliance for Validation, Facilities, Change Control, Investigations, Operations to ensure technically- and scientifically-sound, and GMP-compliant technical decisions and documentation.

Ensuring robust risk management, problem solving, and root cause analyses at the site for investigations, change controls, risk assessments that subsequently ensures effective problem / risk management and reduction, and prevents problem recurrence.

Continuously building up the site quality culture, driving continuous improvement, and building site cohesiveness / relationships.


May also be responsible for or involved in:

Oversight of local GMP suppliers to ensure compliant supplier operations and change management.

Local, corporate and external audits to ensure sufficient support and successful outcomes.

Conducting product complaint investigations to assess distribution / distribution center factors contributing to reported complaints.

Compiling, analyzing and reporting product-specific quality metrics data for annual product review / periodic quality review.


Backup Responsible Person (Backup to Site Quality Manager)

Ensuring that a quality management system is implemented and maintained.

Focusing on the management of authorized activities and the accuracy and quality of records.

Approving the initial and continuous training program for all personnel involved in distribution activities.

Coordinating and performing any recall operations of medicinal products.

Ensuring that relevant customer complaints are dealt with effectively.

Performing the qualification and approval of suppliers and customers.

Approving any contract between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products.

Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

Being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products.

Ensuring that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC.


Other Responsibilities

Perform most work within enterprise applications, such as: ERP (SAP), Quality Systems Application (TrackWise), Document Management Application (Documentum),

Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, simple, and consistent with organizational objectives.



**Additional Information:**




+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #3139488]



Thank you for your interest in the assignment.




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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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.

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Posted: 2020-10-30 Expires: 2020-11-30

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Quality Assurance Specialist

Kelly Services
Shepherdsville, KY 40165

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