The Healthcare Quality Assurance (QA) Specialist maintains the Quality system for the assigned distribution center and projects. He/She communicates Quality policy and objectives and ensures prescribed objectives are met. This position assists with internal audits and validation of the Quality system and processes and participates in assessing the risk and compliance implications of clients' products and pending business opportunities. He/She assists with documenting procedures and interfacing with relevant regulatory agencies to understand and support the application of applicable rules and regulations.
The Healthcare Quality Assurance (QA) Specialist prepares training materials in order to conduct quality training for personnel. He/She follows up on product release to verify and ensure that client specific procedures are being followed. This position attends operations meetings with the Quality Supervisor or Manager to understand clients' businesses. The Healthcare Quality Assurance (QA) Specialist prepares for and assists in conducting internal audits to ensure audit information and observations are captured and recorded. This position supports the writing and revision of standard operating procedures (SOPs) and work instructions to ensure proper procedures are followed by Operations personnel.
* Ensures personnel have been adequately trained on corporate and client specific procedures to ensure adherence.
* Generates, reviews, and approves documentation and reports to support clients' products.
* Supports policy and procedure reviews with clients to determine specialized requirements.
* Prepares and distributes internal audit reports and findings to track and trend audit results and to ensure corrective and preventative actions are taken.
* Assists in coordinating document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards.
* Ensures personnel have successfully completed Good Manufacturing Practices training to ensure compliance.
* Supervises the hold/release process to ensure appropriate product releases.
* Assists in interpreting regulations and procedures for clients to facilitate and ensure compliance.
* Conducts random checks of inbound receipt put-aways to ensure accuracy.
* Supports the implementation of training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics.
* Detail Orientation: Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files.
* Legal, Regulatory, and Compliance Knowledge: Demonstrates a basic understanding of the functions, regulations, and procedures of compliance agencies or governing bodies; takes a leadership position in programs that reduce risk and enhance safety.
* Quality Assurance Knowledge: Communicates quality assurance methodology and explains desired outcomes of testing; identifies the steps in the project life cycle.
* Technical Writing: Demonstrates a general understanding and use of grammatical rules; expresses ideas clearly and concisely; explains the relationship of effective writing to business objectives.
* Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer
* Employer will not sponsor a visa for this or future positions
* Must be currently located in the same geographic location as the job or willing to relocate yourself
* Associate s Degree Science Preferred
Employer will not sponsor a visa for position.
UPS is an equal opportunity employer race/color/religion/sex/national origin/veteran/disability/sexual orientation/gender identity