Quality Assurance (QMS) Specialist
The Opportunity
This position is responsible for quality activities performed within assigned department(s) and for helping ensure compliance with regulatory requirements and internal procedures. Working under general supervision, the Quality Assurance Specialist provides day-to-day quality support to designated departments and serves as a quality leader within their area of responsibility.
What You'll Do
- Support investigation and documentation of observations, deviations, and Nonconforming Product/Material Reports, helping identify potential gaps in the quality system.
- Lead Root Cause Analysis (RCA) meetings as part of the Corrective and Preventive Action (CAPA) process, and assist with CAPA plan implementation and effectiveness checks.
- Support implementation of process changes arising from Change Control through training and direct observation.
- Deliver quality training to new hires and provide ongoing training as needed.
- Perform biannual audits of equipment in assigned areas.
- Maintain visibility into operations through routine direct observation, partnering closely with Operations staff on error prevention.
- Assist with writing and revising Standard Operating Procedures (SOPs).
- Collect and analyze quality data and metrics, and help communicate trends to management.
- Participate in continuous improvement initiatives and project validation teams.
- Support review and retention of Device History Records (DHRs).
- Depending on area of assignment, perform batch record and lot file reviews, in-process and final quality checks, packaging line clearance checks, and related inspections across Manufacturing, Fill/Label, Distribution, QC, QC Lab, and/or BCT Facility functions.
What We're Looking For
Education & Experience
- Associate degree required; Bachelor's degree in a STEM or related discipline preferred.
- 1–4 years of related work experience in an FDA-regulated manufacturing environment; relevant quality experience (2–3 years), preferably in an FDA or USDA industry, may substitute for technical education.
Skills & Attributes
- Strong PC skills, including proficiency with Microsoft Word and Excel.
- High attention to detail.
- Quality auditing certification preferred.
- Accountability, customer focus, professionalism, quality orientation, and a strong team focus.
Work Environment
This role is based in a climate-controlled biological/chemical laboratory, with occasional short-duration exposure to cold temperatures in walk-in coolers. The role requires the ability to wear required cleanroom and personal protective equipment for up to two and a half hours consecutively, and involves standing, walking, lifting up to 55 lbs occasionally, and other physical activity described in the full job description. Travel is estimated at up to 5%.