What are the responsibilities and job description for the Quality Operations Support position at Praxis Packaging?
Overview
Praxis Packaging continues to grow!!! Quality is the key to what we do. We are looking to add a high potential Quality Support professional to our Quality Operations Team to ensure that our products and processes meet all necessary FDA & other regulations and requirements. Strong work ethic, a sense of ownership/accountability, detail orientation, and team-focused communication skills are all required to successfully fill this role.
- This is a 2nd Shift job that will normally work M-F from 3:00pm-11:30pm.
- OT on weekends and extended shifts (stay later to cover part of 3rd Shift) will be required at times.
- Target pay is $25-$28/hr. Hourly pay will be based on the experience and skill level of the applicant.
- Benefits include medical, dental, vision, 401k match, life insurance, STD/LTD, paid Vac/Holidays
Knowledge & Experience:
- Associate degree in Life Science or equivalent, preferred. BS degree is desirable.
- 4 years’ experience in GDP/GMP quality environment required, but equivalent credit can be given for course work.
- Good MS Office or other computer system experience (QMS/LMS), required.
Position Summary:
Works closely with the Production, Quality Operations, Customer Service, and Warehouse to assure all job-related paperwork complies with regulatory and customer requirements. Supports the Quality System Manager and team by supporting key Quality System Programs, including: Document Control, Change Control, Records Control, Internal and External Audits, Food Safety compliance, Annual Product Reviews, Regulatory Filings, and Continuous Improvement initiatives
Essential Functions and Responsibilities:
- Perform Acceptance Quality Level (AQL) sampling and evaluation as required to ensure product quality
- Provides support in the Line Clearance and Cleaning Verification for packaging operations per established Standard Operating Procedures (SOPs) and batch/packaging and labeling records
- Conducts real time (in-process) audits and thorough batch record reviews throughout the production process
- Supports management with a discrepancy or deviation, and provides support to the investigation team
- Provides timely notifications to the customer for incoming quality related issues
- Supports and performs incoming Quality inspections and batch record review regularly
- Serves as mentor/trainer and performs certifications to new Quality members
- Assists with Orientation and GDP/Data Integrity training
- First responder problem solver with Quality issues
About Praxis Packaging:Established in 1989 and headquartered in Grand Rapids, MI, Praxis Packaging Solutions specializes in primary and secondary contract packaging services for the OTC and Rx pharmaceutical, medical device, animal health and health and beauty markets. Praxis is FDA, DEA, and cGMP certified and compliant with production facilities located in Grand Rapids, MI and Randolph, NJ. Praxis Packaging is part of BPOC, a Chicago-based private equity firm that invests exclusively in healthcare companies and is one of the nation's most experienced investors in the industry.
Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.
Pay Range
USD $25.00 - USD $28.00 /Hr.Salary : $25 - $28
