Documentation Specialist, Quality Assurance

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POSITION SUMMARY:

The Documentation Specialist, Quality Assurance will be responsible for ensuring the efficient and compliant execution of reverse logistics processes, including destruction, QA quarantines and/or client holds, reviewing receiving paperwork, managing temperature monitoring data logs, and overseeing pest control documentation. This role also involves assisting on the production floor, resolving issues, and providing guidance to QA Associates. The ideal candidate will have experience in a regulated industry and possess strong knowledge of Good Manufacturing Practices, Good Documentation Practices, and industry-standard reverse logistics best practices.

KEY RESPONSIBILITIES:

• Oversee and manage reverse logistics processes, including product returns, recalls, and damaged goods management, ensuring compliance with industry standards and applicable regulations.
• Collaborate with other departments, including Warehouse, Operations, Inventory Management, and Client Services to facilitate efficient and compliant reverse logistics processes.
• Monitor and manage key performance indicators (KPIs) related to reverse logistics, identifying areas for improvement and implementing corrective actions as needed.
• Develop and maintain standard operating procedures (SOPs) for reverse logistics processes, ensuring alignment with industry best practices and regulatory requirements.
• Participate in audits, both internal and external, and support any corrective actions or process improvements identified during the audit process.
• Oversee and manage Destruction Processes and related SOPs.
• Review receiving paperwork, release from Warehouse inventory management system and ensure compliance with special receiving instructions for specific clients.
• Download and escalate temperature monitoring data logger reports with receiving documents to Client Services and save into client-specific folders.
• Review and file all receivers, receipt-by-date reports, and job jackets.
• Oversee pest control documentation, signing off on monthly vendor-supplied documents
• Coordinate archiving of year-end files, receivers, job jackets, SOD waves, and production waves.
• Assist on the production floor and address any issues or concerns raised by QA Associates.
• Execute additional duties as assigned by QA Management, including serving as backup for select QA Associate tasks and activities.
• Conduct root cause analysis of non-conformances related to reverse logistics processes and implement appropriate corrective and preventive actions.
• Maintain documentation and records related to reverse logistics activities in accordance with Good Documentation Practices and applicable regulations.
• Provide training and support to QA Associates on reverse logistics processes and best practices.
• Ensure proper disposal or recycling of returned, recalled, or damaged products, in accordance with government environmental regulations and company policies.
• Stay current with industry trends and regulatory changes related to reverse logistics in the pharmaceutical industry and ensure that the company's processes and procedures are updated accordingly.

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

MINIMUM JOB REQUIREMENTS:

• High School Education or GED.
• Two to three years of experience in a Quality Department, and/or experience with Reverse Logistics functions strongly preferred.
• Experience within a regulated industry strongly preferred.

KNOWLEDGE, SKILLS & ABILITIES:

• Strong mathematical skills (add, subtract, multiply, divide, compute rate, ratio, and percent).
• Excellent oral and written communication skills, with proficiency in English; Spanish speaking is a plus.
• Flexibility to adapt to the demands of the position.
• Knowledge of ANSI sampling standards, current Good Manufacturing Practices, and Good Documentation Practices.
• Proficiency in Microsoft Excel (intermediate level) and Word (basic level).

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 pounds.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an equal opportunity employer.