195632 - Quality Assurance Specialist
NJ-New Jersey
Fair Lawn
$25 to $35.00 DOE
12 mos
Chipton-Ross is seeking a Quality Assurance Specialist for an opening in Fair Lawn, NJ.

Collecting all supporting documentation from Process. Owners/SMEs to support the Change Request, including but not limited to supplier supplied documentation and in-house data. Documenting the Change Proposal per LCD procedures. Route all changes for impact assessments and signatures. Logging and Issuance of Change requests to impacted areas for completion of tasks via the document control process. Performing follow-up activities with Process Owners/SMEs to ensure all implementation tasks are completed and documented in the Change Management System by Tracking of task completion to ensure closure of change required deliverables. Performing records retention activities to ensure Change Management records are readily retrievable. Drafting and routing of Customer Notifications as required. Generating task related metrics and presenting to project managers/leadership.

Experience with change management. ISO, Pharma or Med device as well is preferred. Material purchasing exposure, Project management skills. Experience with QMS databases such as Agile and Trackwise preferred. Knowledge of the most recent version of ISO9001. FDA GMP a plus. Skilled at reporting metrics showing performance and trending. Ability to manage numerous priorities and activities in parallel. Excellent verbal and written communication skills; ability to write reports required. Excellent organizational skills and be detail oriented.

Accredited Bachelor’s Degree in Science or Engineering


Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Kristie Hardage
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x251 or (800) 927-9318 x251

To ensure compliance with President Biden’s September 9, 2021 executive order, the client is implementing a new requirement for U.S.-based employees to either show proof of being fully vaccinated from COVID-19, or have an approved reasonable accommodation (based on a disability/medical condition or sincerely held religious belief) exempting them from the requirement, by December 8, 2021 (timing may vary in some states). Individuals who are unable to meet COVID-19 requirements due to a disability/medical condition or sincerely held religious belief may apply for a reasonable accommodation during the post-offer process. Individuals with approved accommodations will be subject to frequent COVID-19 testing.

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.