Knipper Health · 15 hours ago
Quality Assurance (QA) Associate II
US-NJ-Lakewood
Full-time
Onsite
Entry Level
$20/hr - $24/hr
1+ years expKnipper Health is a company focused on maintaining quality standards in the healthcare sector. They are seeking a Quality Assurance (QA) Associate II who will perform inspections, complete quality documentation, and ensure compliance with regulatory standards.
MarketingPharmaceutical
Responsibilities
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
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
Qualification
Required
High School Education or general education degree minimum
Strong written and verbal communication skills
Proficient computer skills include Microsoft Outlook for professional communication
Proficient computer skills include Microsoft Word for controlled documentation and reports
Proficient computer skills include 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
Preferred
1-2 years of Quality Assurance experience in a regulated environment (pharmaceutical, medical device, food, or similar preferred)
Working knowledge of cGMP preferred
Company
Knipper Health
Knipper Health is a pharmaceuticals company offering sampling distribution and prescriber validation services.
501-1000 employees
H1B Sponsorship
Knipper Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (1)
2022 (6)
2021 (6)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Frazier Healthcare Partners
2025-07-08Private Equity
Leadership Team
Michael Laferrera
President and Chief Executive Officer
Joseph Schmadel
CDO / CIO
Recent News
Fierce Healthcare
2025-08-06
Company data provided by crunchbase