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Sr Quality Systems Spec - Exempt

HireTalent

Plymouth, MN

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JOB DETAILS
SKILLS
Analysis Skills, Auditing, Best Practices, Board Meeting, Coaching, Communication Skills, Computer Software, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Documentation, Government, Government Regulations, Interpret Regulations, Leadership, Legal Support Skills, Litigation, Maintain Compliance, Mentoring, Microsoft Exchange Server, Organizational Skills, People Management, Process Analysis, Process Improvement, Process Management, Process Validation, Project Design, Project Tracking, Project/Program Management, QoS (Quality of Service), Quality Assurance, Quality Management, Root Cause Analysis, Software Validation, System Validation, Systems Administration/Management, Talent Management, Team Player, Technical Writing, Time Management
LOCATION
Plymouth, MN
POSTED
30+ days ago
Must Have:

Prior CAPA Owner or CAPA Specialist

Nice to Have:

1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge

JOB DESCRIPTION
Spotlight Call with the HM:
2/26 - 4pm CST
+***
Phone conference ID: 146 544 425#


Target BR Max: *** ***/hr

HM's Top Needs:
CAPA Experience (ownership or CAPA specialist)
Organizational skills manage a large # of tasks, keeps them progressing and completing on time.
Collaborative able to work with owners to help them make the best documentation possible.
This person needs to be able to:
Handle the system administration of the our client CAPA Management System (Trackwise)
Organize and conduct CAPA Board meetings.
Ensure and aid CAPA owners in the creation of compliant CAPA documentation
Aid CAPA Owners by critically reviewing Investigation Plans, Root Causes, Action Plans, and Effectiveness Plans.
Aid CAPA board members by providing insights regarding the CAPAs and how the corrective actions will impact the production facility.
Ensure on-time progression of CAPA activities to the specified due dates.


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: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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