Kelly Services Quality Associate II in St. Paul, Minnesota

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Quality Associate at a prestigious Fortune 500® company working in St. Paul, MN.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( however your resume must be received via the “Submit Resume” button included within.

Job Title: Quality Associate

Pay: $21.25

This position is responsible for serving as subject matter expert for assigned Quality Systems processes, including but not limited to, Document Management, document Change Control for product, process, and QMS documents. This position is also responsible for serving as the ISOTrain Local Divisional System Administrator (LDSA) for St. Paul (Synovis) and Birmingham (SMCA). In addition, this position is a key member of the External Audit Readiness team. As a member of the External Audit Readiness team this position acts as the Back Room Administrator coordinating document request logs and preparation of requested documents for presentation in the Front Room by SME. DCR & Deviation Coordinator • Take leadership and/or subject matter expert role in normal day-to-day activities, routine and special projects, and continuous improvement efforts supporting assigned Quality Systems processes: Change Control • Meet yearly objectives for role • Coach and assist other employees whose roles and responsibilities require them to work within the Quality System and meet Quality System process requirements • Create, update and maintain procedures and any other documentation for assigned Quality Systems processes. • Establish and maintain, trend, and report data/metrics for assigned Quality Systems processes • Identify and work on Quality Systems process improvement projects • Interact regularly with peers in Quality Systems and other functional areas • Interface with similar functions at corporate/division and at other manufacturing sites as required for assigned Quality Systems processes • Represent assigned Quality Systems processes during regulatory and / or internal audits as requested • Act as backup resource for other Quality Systems processes as needed • Perform other duties as assigned LDSA • Act as local site administrator and subject matter expert for LMS, to include creation/assignment of training courses/modules/curricula and recording training completion data • Support St. Paul and Birmingham (MCA) LMS as assigned • Maintain accurate training records and metrics that provide evidence of completion of the assigned required training that is necessary for competent job performance and the health of the training system. • Provide technical expertise to lead and/or support assessment, design, implementation, delivery, and effectiveness evaluation of training, including creating new classroom and hands-on/OJT programs as warranted • Manage training and development calendar, and define and execute communication plans to support St. Paul and Birmingham ISOTrain training activities • Establish and maintain, trend, and report training data/metrics for ISOTrain • Support training for new systems being implemented (e.g., LIMS, CAPA, TrackWise Change control and TcU Document Management) • Interface with ISOTrain training functions at corporate/division and at other manufacturing sites as required • Develop relationships and manage internal and external partners in the design and delivery of training services, as needed External Audit Readiness team this position acts as the Back Room Administrator • Monitors Front Room activity for document request and audit trends • Maintains Audit Request Log • Maintains Audit Conversation Log • Aids in retrieval and preparation of requested audit documents • Back up document runner during external audits • Aids in planning and execution of Mock Audits to maintain audit readiness • Assists Back Room Lead with preparation and coaching of SME prior to SME presenting in Front Room To perform essential duties and responsibilities of the position, the following knowledge, skills, and abilities are required. • Ability to administer all required automated electronic system (e.g., Grand Avenue Software, BPLM, TcU, TrackWise) functions for assigned Quality Systems processes • Subject matter expertise in assigned Quality Systems processes, • Ability to administer all required LMS functions and serve as site subject matter expert for LMS • Ability to adapt and implement training to support changes in work processes and systems. Effective presentation skills and group facilitation skills • Ability to communicate clearly and accurately in both verbal and written form in all job-related activities • Knowledge and application of Good Manufacturing Practices (GMP) • Knowledge of applicable procedures, specifications, regulations and standards. • Strong analytical skills and process orientation • Ability to work effectively with all levels of the organization • Ability to work with minimal supervision • Ability to manage workload effectively • Ability to collaborate effectively • Strong influencing and negotiating skills • Strong project management skills • Strong organizational skills • Strong interpersonal skills • Good problem-solving skills • Computer proficiency including use of standard business productivity software (e.g., Microsoft Office applications) Undergraduate 4-year degree in science, engineering, or other academic discipline that supports role and responsibilities; or equivalent professional experience. 3-5 years of experience in Quality, or related field in the medical products or other regulated industry. Working knowledge of, and effective interpretation and application of, Quality Systems regulations and ISO requirements. • Frequent standing/walking. • Ability to sit/stand at computer workstation and use computer keyboard to enter data, develop materials, etc.

• Minimal travel required. • Working environment includes normal office working conditions • Must be able to enter and work in controlled environments requiring special gowning as needed. Will be required to follow gowning requirements when entering these areas. • Personal Protective Equipment as needed.

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Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

Why Kelly®? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]]

Category: Biotech/Clinical/R&D/Science