MQA Technician 1- 2nd shift de Cary, IL em Stryker Corporation

Data de Postagem: 7/22/2019

Resumo do Emprego

Descrição do Emprego

Position Summary:

Under general supervision; this position will support the goals in processing regulatory documents in electronic and hard-copy median; with strict adherence to regulations. As a Manufacturing Quality Assurance Technician, you will be required to review, manage and facilitate the activities related to the release of finished product and associated components into the market for consumer use. The Manufacturing Quality Assurance Technician role will also serve as a point of contact/liaison and support Manufacturing Operations. 

Essential Duties and Responsibilities:

  • Perform documentation activities that adhere to cGMP and GDP.
  • Review and release of all batch record documentation against product specific criteria.
  • Review and release of manufacturing protocol runs.
  • Review and release of all manufacturing component and work in progress (WIP).
  • Review and mark for corrections per cGMP and GDP guidelines, log records, batch records and other controlled documentation.
  • Provide support to manufacturing through:
    • Answering questions on document revisions and errors
    • Intervention/overrides as needed with shop floor data collection
    • Timely decision making on product quality issues
    • Obtaining corrections on documentation errors and providing explanation where required as pertains to cGMP
  • Initiation of Nonconformance investigative reports within the TrackWise system.
  • Maintain various spreadsheets and databases (requires heavy use of Excel, Word, MS Outlook and similar database programs).
  • Communicate with Warehouse and Manufacturing personnel regarding the release and movement of materials/components.
  • Communicate with various departments regarding the release status of materials.
  • Update the release status of materials electronically to indicate acceptance or rejection.
  • Work with Shipping Warehouse personnel to accept returned products and update release status as required.
  • Perform other duties as assigned

Education & Special Trainings:

  • Associates Degree or equivalent job experience.

Qualifications & Experience:

  • General knowledge of FDA regulations for drugs and medical devices.
  • Exceptional organizational and communication skills.
  • Ability to perform review of documentation with a high level of attention to detail.
  • Ability to take direction, work independently as well as with a team and be adaptable in an ever-changing environment.
  • Capability to handle heavy computer use and work in multiple systems.
  • Proficiency with Microsoft Office (Word, Excel, etc.) required.
  • Aptitude to multi-task and prioritize work.
  • Possesses a high level of personal integrity and self-control.
  • Physical capability to lift 50 pounds and be mobile throughout a large plant.
  • Accepts direction and constructive criticism.

Physical Requirements:

  • Subject to controlled indoor conditions with some temperature change from occasional task in the warehouse. May be subject to short-term exposure to some hazardous chemicals and reagents.
  • Physical activities include: Standing, walking, sitting, lifting up to 50lbs, carrying, reaching, handling, talking, hearing, pulling, pushing, keying, grasping.
  • Visual activities include: Must be capable of accurately discerning instrument/equipment displays.  Good color discrimination.

Mental Requirements:

  • Long periods of concentration including sample inspection, testing and review of documents.  Participation in discussions and planning. 

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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