Quality Assurance Specialist - Medical Device

Socket.dev; Tennessee; On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Competitive pay

Time off & holidays

Healthcare benefits

401k match

Job summary

Crown seeks a QA Specialist to ensure quality compliance on the production floor and assist with product/kitting release, batch record and procedure reviews. This role reports to the QA Manager – Medical Device and is based in Johnson City, Tennessee, with standard Monday–Friday hours.

The candidate will perform audits, inspect materials, approve minor deviations, and help train staff in GDocP while ensuring adherence to regulatory guidelines and company procedures.

Qualifications

• 0-2 years’ experience in Quality Assurance, Manufacturing or regulated industry.
• Knowledge of cGMPs and regulatory requirements for Crown Aesthetics products.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Excellent verbal and written communication; ability to work independently.
• Ability to stand for several hours and lift up to 20 lbs.

Responsibilities

• Perform audits/checks of incoming and in-process processes including QA checks and line clearance.
• Perform Safe Launch and Safe Exit inspections for specified products.
• Receipt and inspection of RMA material.
• Review and approve batch records for completeness and accuracy for batch release.
• Verify compliance with regulatory and company procedures and guidelines.
• Assist with training floor personnel in GDocP.

Skills

cGMPs

MS Office

Verbal communication

Written communication

Independent worker

Job description

Job Summary

The QA Specialist is responsible for performing Quality compliance activities on the production floor and ensuring that all activities are in compliance with company and regulatory guidelines and procedures. In addition, the QA Specialist is also responsible for assisting in activities directly related to in-coming product/kitting release, batch record & procedure review.

Job Information

• Reports to: QA Manager – Medical Device
• Reports to: QA Manager – Medical Device
• Location: Johnson City TN
• Hours: Monday-Friday 8AM-4PM

Responsibilities / Essential Duties

• Perform audits/checks of incoming and in-process processes to include QA checks, line clearance activities, record review and signoff, labelverificationand reconciliation verification.
• Perform Safe Launch and Safe Exit inspections for specified products.
• Receipt & inspection of RMA material.
• Approve minor deviations on the operation floor.
• Review and approve executed batch records for completeness and accuracy for batch release.
• Verify and ensure compliance with regulatory and company procedures and guidelines.
• Assistwith training floor personnel in GDocP.
• Perform investigations asrequired.
• Assistin other quality-related functions as requested.
• Assistwhen applicable in kitting area, reporting to the area leadership team
• Timeutilizationto be shared with kitting department as needed.
• Additionaltasks as assigned by Quality Management and/or Kitting Leadership

Job Related Qualification/Skills

• Minimum of 0-2 years’ experience in Quality Assurance,Manufacturingor regulated industry.
• Demonstratedknowledge of cGMPs, other regulatory requirements for the manufacture, testing and release of Crown Aesthetics products.
• Strongproficiencyin Microsoft Office suite of products, (Word, Excel, PowerPoint)
• Excellent verbal and written communication skills.
• Excellent interpersonal, communications and organizational skills as well as the ability to work independently.
• Must have the ability to stand for several hours, lift approximately 20lbsrepetitively, unstack/restack pallets so to pull ANSI AQL samples

Company Summary

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you

• Competitive Compensation including base salary and annual performance bonus
• Paid time off, holidays, and floating holidays that can be used for whatever you choose
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual’s race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.