Quality Assurance Specialist

job summary:
The Quality Assurance Inspector is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. The Quality Assurance Inspector is part of the Quality Assurance Inspection (QAI) Department at Ridgefield, NJ.

location: Ridgefield, New Jersey
job type: Contract
salary: $25 - 27 per hour
work hours: 9 to 5
education: High School

responsibilities:
This role is responsible for performing incoming and in process inspection and be knowledgeable in the following:

- Make sound decisions regarding packaging inspections, rework operations and final disposition of incoming materials according to company policies and procedures with minimum supervision.

- Strategically prioritize in-coming inspections to accommodate Manufacturing's needs.

- Act as liaison with suppliers as necessary to resolve quality issues.

- Provide quality expertise and support to the Packaging and Manufacturing Operations site (Quality Oversight, logbook/AQL Inspection Forms review, solve issues real time with operations personnel, etc.)

- Participate in process improvements to eliminate redundant inspections/ sampling.

- Well versed in ANSI.ASQ Z1.4 sampling plans

- Familiar with AQL sampling, normal, reduced, and tightened inspections and switching rules.

- Working knowledge of cGMP as it relates to inspection activities.

- Possess the ability to read and interpret component drawings and use measurement tools such as calipers and micrometers.

- Possess the ability to evaluate certificate of analysis of chemicals/raw materials/packaging components.

- Collaborate with Purchasing Department and Suppliers to resolve incoming inspection paperwork discrepancies and shipping issues.

- Possess strong organization, communication, writing, people skills/teamwork and detail oriented.

- Experience working in a team environment, facilitating a team approach, and communicating effectively.

- Practice safe work habits and adhere to company safety procedures and guidelines

- Maintains compliance to company policies and procedures.

- Knowledge of medical device or drug packaging operations.

qualifications:
- High School Diploma (or higher) with 1-3 years experience within a GMP environment.

- Experience with SAP ERP system, QualiPSO, iLearn, Trackwise and STARLIMS a plus.

- Knowledge in CGMP/regulatory compliance

skills: ERP System, Good Manufacturing Practices (GMP)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.