Quality Specialist II

YOUR PASSION, ACTIONS & FOCUS is our Strength.

Become one of our Contributors!

Join the KnipperHEALTH Team!

The Quality Specialist II is responsible for monitoring and ensuring compliance with the Drug Supply Chain Security Act (DSCSA) procedures and processes, including coordinating labeling, reviewing exceptions, conducting investigations, and executing process audits. Additionally, the role requires ensuring that quality and safety standards are met and maintained in accordance with current Good Manufacturing Practices (CGMP), Good Distribution Practices, and Knipper standard operating procedures for the storage and distribution of FDA-regulated medical devices, pharmaceutical samples, cosmetics, and other products.

Full Time Onsite role based out of Charlestown, Indiana location. Typical hours are Monday-Friday 8:00am ET- 4:30pm ET.

   KEY RESPONSIBILITIES:

• Coordinate the maintenance and update, as applicable, of Risk Management Files and reports as assigned Provide backup to the Quality Supervisor, Quality Associates, and other Quality personnel.
• Maintain and update quality records in hard copy, the eQMS, ERP, WMS, and other systems as defined.
• Execute validation and verification protocols as assigned.
• Review and file QA receiving paperwork, ensuring compliance with client-specific receiving and inspection requirements. This may include client services notification communications.
• Interact with internal and external departments, including clients, vendors, and regulatory agencies.
• Works directly with stakeholders to investigate nonconformances and deviations, including their impact on products and processes and the root cause. As needed, initiates and communicates Supplier Corrective Action Requests (SCARs) to suppliers.
• 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.
• Support client and regulatory agency audits.
• Execute internal and supplier (vendor) audits as assigned.
• 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.
• Ensuring quality and safety: Ensure quality and safety standards are met and maintained per CGMP and Knipper standard operating procedures.
• Ensure all related processes are followed per company policies.

Responsibilities for DSCSA Assignment

• Responsible for first article coordination, inspection, and approval of serialization master labels in support of Knipper's Drug Supply Chain Security Act (DSCSA) procedures and processes.
• Review and approve exceptions as defined by the Drug Supply Chain Security Act, coordinating with process owners and subject matter experts to ensure the appropriate resolution and objective evidence are on file.
• Act as the Quality representative for Knipper’s EPCIS team.
• Conduct hard copy documentation and electronic data reviews to support investigations into serialization exceptions, deviations, and nonconformances.
• Author, review, approve, and revise standard and job or client-specific work instructions related to the receipt, distribution, and return of distributed projects subject to DSCSA
• Train Quality Associates and other contributors, as requested, to Knipper’s processes to maintain DSCSA requirements regarding the appropriate resolution of exceptions, missing files, deviations, shortages, overages, and inspection events.
• Track, trend, and analyze serialization-related quality issues.
• Define and execute process audits to monitor compliance with DSCSA in applicable processes, including, but not limited to, receiving, distribution, recalls, returns, shortages, overages, and destructions.
• Work with the EPCIS team, Client Services, Operations, Quality, and other departments as needed to document, communicate, and resolve DSCSA discrepancies identified upon receipt of or during Knipper’s handling and distribution of products.
• Maintain a working knowledge of DSCSA requirements and best practices (FDA, GS1).

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

MINIMUM JOB REQUIREMENTS:

• Bachelor's degree or equivalent experience.
• 2 – 5 years of Quality process experience in a regulated industry focusing on deviation, nonconforming material, complaint, or other relevant CAPA processes. Pharmaceutical or medical device background is strongly preferred.
• Experience inspecting or verifying GS1 Data Matrix and barcoding for products supplied into healthcare environments
• Experience working in an eQMS and WMS/ERP system
• Proficient in Microsoft Office applications. WORD Level – basic skills required; EXCEL – Intermediate Level required

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to perform fundamental data analysis, such as identifying trends, creating visualizations, and interpreting summary data.
• 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
• Able to interpret regulatory standards and guidance documents.
• Strong knowledge of CGMP, Good Documentation Practices, and ALCOA+ is required.
• Ability to maintain the highest level of confidentiality.

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.