Under general supervision; this position will support the goals in processing incoming raw materials and components. The Senior Incoming QA Technician will be required to sample and inspect incoming raw materials against approved specifications and incoming inspection plans. The role will also serve as a support role for IQA daily responsibilities and as a point of contact/liaison and support routine Manufacturing operations.
Essential Duties and Responsibilities:
Provide support to IQA technicians across two shifts and trouble shoot issues related to the review and release of product.
Coordinate daily scheduling and planning of product sampling, inspection and release.
Participate in projects as they pertain to IQA.
Conduct revisions to procedures and forms as well as document approvals.
Perform origination and owner responsibilities for Nonconformance investigative reports within the Agile/TrackWise systems.
Perform documentation activities that adhere to cGMP and GDP.
Perform inspection activities for various raw materials, components & finished goods conformance to the specification or drawing.
Sample and test received raw materials, components & finished goods that require inspection and release prior to use in manufacturing.
Use of aseptic techniques to sample chemicals and raw materials.
Use of various measurement tools and instruments: calipers, scales, thickness gauges, force gauges, optical comparator, Raman spectrophotometer, pipets, and other systems.
Perform inspection activities of printed materials against master documents for differences.
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.
Perform other duties as assigned.
Education & Special Trainings:
Associates degree required, Bachelor's degree preferred.
At least 3 years 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 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 60 pounds and be mobile throughout a large plant.
Accepts direction and constructive criticism.
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 60lbs, carrying, reaching, handling, talking, hearing, pulling, pushing, keying, grasping.
Visual activities include: Must be capable of accurately discerning instrument/equipment displays. Good color discrimination.
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.