Job Description

OVERVIEW :

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Systems Document Specialist

** JOB ID: 51516

** JOB TITLE: Quality Systems Document Specialist

** LOCATION: Onsite Role | 1 Becton Drive Franklin Lakes NJ 07417

** DURATION: 12 months +

Pay Rate: $30.00/hr. - $34.00/hr. W2 (depending upon experience)

• Must have: Serves as primary support for the conversion of Quality System Procedures and Records from IDS business unit to SM business unit format and content.
• High proficiency in Microsoft Word / Document Management is required.
• Ability to prepare or revise policies, procedures and revise documents with a high degree of accuracy and efficiency.
• This is primarily high-volume work in Microsoft Word.
• The Sr. Quality System Specialist is accountable for support of the continued development, improvement, and implementation of the Quality Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities.

JOB RESPONSIBILITIES:

• Consistent application of quality system standards to assigned quality system area.
• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company/Unit procedures and may make updates to procedures and policies.
• Works within and across functions for assigned quality systems.
• Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.
• Serves as primary support for the conversion of Quality System Procedures and Records from IDS business unit to SM business unit format and content.
• May perform other duties as required.

JOB REQUIREMENTS:

• Education: Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.
• High proficiency in Microsoft Word / Document Management is required.
• Ability to prepare or revise policies, procedures and revise documents with a high degree of accuracy and efficiency.
• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
• Working knowledge of applicable Corporate and/or Unit requirements
• Contributes to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower-level project developers.
• Can independently determine and develop approach to solutions.
• Ability to work independently within defined parameters under minimal supervision.
• Can develop solutions to routine assigned activities of moderate scope & complexity.
• Experience with client software systems utilized in the Quality Systems is desirable.
• SAP, Trackwise, PEGA
• Certified Quality Auditor or Transactional Six Sigma Green Belt desirable.

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Recruiter Name: Lalit Malgotra

Title: Lead Recruiter

Email ID: [email protected]

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.

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