Quality Specialist I - Charlestown

Overview :

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The Quality Specialist I will be responsible for ensuring the efficient and GMP compliant execution of logistics and quality processes, including reviewing the receiving and distribution operations paperwork, recording quality results, including organizing and providing documentation to clients and other Knipper departments.

Responsibilities:

• Review and file receiving paperwork, ensuring compliance with client-specific receiving and inspection requirements. This may include client services notification communications.
• Release product from warehouse inventory management system as needed
• Management of temperature data loggers and its data, and escalation as required.
• Manage product discrepancy paperwork and process (damages, overage/shortages) for assigned business units
• Effective implementation and monitoring of the client requested inventory status change process, including verifying status in the WMS, reviewing and storing applicable forms and documentation, notifications and follow up.
• - Interact with internal and external departments including clients, vendors, and regulatory agencies.
• Works directly with stakeholders to investigate non-conformances and deviations, including product and process impact, and root cause. Initiates and communicates Supplier Corrective Action Requests (SCARs) to suppliers, as needed.
• Support the performance of Quality Investigations, verification of implementation of Corrective and Preventative actions, Effectiveness Checks and Change Control in support of assigned business units.
• Utilization of Knipper’s computer software including but not limited to: eQMS (Track-Wise), WMS (SCALE)
• Support Client and regulatory agency audits and inspections as assigned.
• - Assist on the operations floor and address any issues or concerns raised by QA Associates and serving as a backup to the QA Lead.
• Execute additional duties as assigned by QA Management, including serving as backup for select QA Associate tasks and activities, and gathering and organizing data for quality management reporting.
• Provide training and support to QA Associates on related processes and best practices.
• Ensuring quality and safety: Ensure that quality and safety standards are met and maintained in accordance with cGMP and Knipper standard operating procedures.
• Ensure all related processes are followed in accordance with company policies.

The above duties are meant to be representative of the position and not all-inclusive.

Qualifications:

MINIMUM JOB REQUIREMENTS:

• High School Education or GED
• 1-2 years of experience in a relevant quality department experience in an FDA regulated environment
• Pharmaceutical or medical device background strongly preferred
• Experience working in an eQMS and WMS/ERP system

KNOWLEDGE, SKILLS & ABILITIES:

• Intermediate mathematical skills (add, subtract, multiply, divide, compute rate, ratio, and percent)
• Good oral and written communication skills, with proficiency in English; Spanish speaking is a plus
• Flexibility to adapt to the demands of the position
• Able to interpret ANSI sampling standards
• Working knowledge of current Good Manufacturing Practices and Good Documentation Practices
• Proficient in use of computers, including intermediate level in Microsoft Excel and Word

PHYSICAL DEMANDS:

• Frequently required to stand or sit
• Regularly required to reach, pull, stoop, bend, kneel and/or crouch
• Occasionally lift and/or move objects up to 35 lbs.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an equal opportunity employer.