Quality Assurance (QA) Associate II

Knipper HEALTH•Lakewood Township, NJ

About The Position

Maintains quality standards by performing incoming, in-process and finished product inspections with an increased level of independence and technical proficiency. In addition to routine inspection activities, the Quality Associate II is responsible for accurate, timely, and compliant completion and review of electronic quality documentation and systems. Ensures compliance with CareTria Quality Policy, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), Operations Work Instructions (OWI), other documented instruction, and all safety measures.This role is an individual contributor position and does not include supervisory or lead responsibilities.

Requirements

High School Education or general education degree minimum.
Strong written and verbal communication skills.
Proficient computer skills include:
Microsoft Outlook for professional communication
Microsoft Word for controlled documentation and reports
Microsoft Excel for data entry, review, basic analysis and reconciliation. (e.g. filters, sorting)
Ability to accurately navigate and utilize electronic quality management systems (eQMS), inventory systems, or similar databases
Demonstrated ability to accurately review, reconcile, and maintain electronic and paper quality records.
Ability to work independently within established procedures and escalate issues appropriately.
Ability to perform basic mathematical calculations and understand ratios, rate, and percentages across units of measure.

Nice To Haves

Preferred: 1-2 years of Quality Assurance experience in a regulated environment (pharmaceutical, medical device, food, or similar preferred).
Working knowledge of cGMP preferred.

Responsibilities

Performs inspections in accordance with documented procedures and inspections for: incoming material (including returns),
kitting and relabeling processes (including serialization projects
print processes,
distribution processes (e.g. pick module, cold chain, DEA cage)
reverse distribution processes (e.g. destructions)
any other operationally or client directed inspection activities
Assists with special projects as required (e.g. physical inventories, special client-driven inspections and projects)
Documents all inspection results by completing forms, reports, and logs; verifying operation completions as required; escalates nonconformances found
Download portable temperature monitoring devices and send them to client and/or client services team. (This may include additional software or client-specific logins)
Supports document control activities, including review for completeness, legibility, and compliance prior to filing or archiving.
Maintains organized, accurate, and readily retrievable quality records in accordance with regulatory and company requirements.
May escort vendors for pest control, scale calibration and environmental monitoring.
Utilizes electronic quality systems, spreadsheets, and databases to enter, track, review, and retrieve quality data and inspection records.
Identifies and escalates nonconformances, documentation discrepancies, and data integrity issues in a timely manner.
May escort vendors for pest control, scale calibration and environmental monitoring.
May support audits, inspections, or data requests by locating and compiling quality records.
Maintains safe and healthy work environment by following standards and procedures.
Actively maintains job knowledge by reviewing SOPs, Work Instructions, and participating in required training.
Reports all concerns and questions to management
The above duties are meant to be representative of the position and not all-inclusive.