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Quality Systems Spec

Heritage Creek, KY 40219

Posted: 02/10/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617549 Is job remote?: No Country: United States

Job Description


Contract through FYE (4/25/25)- will ask about extension potential on the SLC
Target BR: 55-75/hr (Pay 36-50.50)
Louisville, KY

HM's Top Needs:

  1. Experience working in Quality for minimum 2 years

  2. Experience with CAPA Root Cause Analysis tools and Auditing

  3. Ability to work independently since this person will be at a 3PL site as the MDT quality rep.

Education Required: Bachelorrsquos

Yearsrsquo Experience Required: 2

 

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs systems processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines. Provides expertise and guidance in interpreting policies regulatory and/or governmental regulations and agency guidelines to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Coordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing thereby fostering the achievement of company's mission globally.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information status needs and issues in order to inform gain input and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience or advanced degree with 0 years of experience.
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About Heritage Creek, KY

Discover exciting job opportunities in the vibrant city of Heritage Creek, Kentucky! Nestled in Jefferson County, this charming town offers an ideal blend of small-town charm and big-city amenities. With its rich history, stunning parks like McNeely Lake Park, and a burgeoning arts scene featuring galleries like Swanson Contemporary and live performances at the Kentucky Center for the Performing Arts, Heritage Creek is a hidden gem for career growth. Indulge in the local flavors of famous Kentucky BBQ and enjoy a game day with the Louisville Cardinals or the Kentucky Derby at Churchill Downs. Explore job listings in this dynamic region and unlock your potential in Heritage Creek, where every day is filled with new adventures and opportunities.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.