[ref. v55475121] Supervisor, Quality Assurance

Overview :

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The Quality Supervisor is responsible for the oversight of incoming receiving, in-process, and final inspection activities to ensure Knipper's receipt, handling, kitting, and distribution of FDA-regulated prescription and OTC drugs, medical devices, cosmetics, and other products are processed following Current Good Manufacturing Practices (CGMP), Good Distribution Practices (GDP), Drug Enforcement Agency (DEA), Client and other standards or regulations and the applicable specific client programs such as medicinal sample management and 3PL.

Full Time On-site Role based out of Charlestown, Indiana location; typical works hours are Monday-Friday 8:00am -4:30pm ET.

Responsibilities:

KEY RESPONSIBILITIES:

• Train, mentor, and evaluate the performance of Quality Associates to ensure competency and awareness of Knipper's regulatory and Client expectations and requirements.
• Implement and monitor standard work and best practices to optimize the efficiency of QA Associate activities.
• Supervise the day-to-day activities of Quality Associates to ensure workloads are balanced across MSM and 3PL Operations, receiving, picking, kitting, and activities as required.
• Provide Quality Approval and disposition of products for release.
• Support the execution of Quality department-assigned investigations, verification of implementation of Corrective and Preventative actions, Effectiveness Checks, and Change Control in support of assigned business units.
• Work directly with internal departments and clients (as applicable) as a subject matter expert to investigate and resolve non-conformances, deviations, and DSCSA exceptions, including their impact on products and processes, and to determine the root cause.
• Analyze data from critical to quality sources and Key Performance Indicators to identify trends to determine the need for additional investigation, escalation to CAPA, and areas for improvement.
• Drive and support cross-functional teams to ensure the appropriate controls are in place and effectively identify and segregate all defective, damaged, or returned materials until final Quality disposition.
• Support facilities management in overseeing the pest control program, including the sign-off of pest control routine and for-cause treatments and inspections and authoring annual trend reports.
• Coordinate with Operations, Quality, Client Services, and other management personnel to resolve quality issues.
• Monitor and support all activities and documentation of Quality Associates to ensure adherence to established quality standards, including, but not limited to, Knipper Standard Operating Procedures, Operating Work Instructions, and Client Standard Operating Procedures.
• Monitor production processes and ensure they comply with documented requirements.
• Escalate concerns to Knipper's Quality and Compliance management as appropriate.
• Ensure the appropriate segregation, risk assessment, and documentation of products impacted by environmental excursions.
• Review Environmental Monitoring data at the defined report frequencies.
• Initiate, communicate, and track Supplier Corrective Action Requests (SCARs) to suppliers.
• Utilize Knipper's computerized software to support and document Quality activities including but not limited to eQMS (TrackWise), WMS (SCALE)
• Engage with external entities, including clients, vendors, and regulatory agencies.
• Support Client and regulatory agency audits and inspections as assigned.
• Serve as a backup for QA management, Associates, and Quality Specialists.
• 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: Quality and safety standards are met and maintained under CGMP and Knipper standard operating procedures.

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

Supervisory Management:

• Will carry out supervisory responsibilities in accordance with the company’s policies and applicable laws, including but not limited to review and approvals of timecards, resource hours, and required trainings.
• Responsibilities include training, planning, assigning and directing work; appraising performance; motivating, developing and disciplining employees; addressing complaints and resolving conflicts.

Qualifications:

MINIMUM JOB REQUIREMENTS:

• High School Education or GED
• 2-3 three years of experience of supervising Quality teams in a regulated environment. Pharmaceutical or medical device background strongly preferred.
• Experience working in an eQMS and WMS/ERP system such as TrackWise, Microsoft Dynamics and SCALE.

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
• 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 the use of Microsoft Office programs, 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

Knipper Health is an equal opportunity employer.