Associate I, Quality Assurance

BioTissue Holdings Inc • FL

87d

About The Position

In this position the incumbent is responsible for supporting the product release process, by ensuring that all products meet quality standards before executing the release for distribution. This role involves reviewing product documentation, and collaborating with cross-functional teams to ensure the final product is of the highest quality. The incumbent will also perform various additional duties for the Quality department including manual &/or electronic filing and retrieval, data entry, creating documentation by hand &/or electronically. The incumbent will work closely with various GMP/GTP related departments (i.e., Production, Supply Chain, Facilities & Distribution) and support compliance.

Requirements

• Must have effective communication and people skills across all functions within the organization and outside.
• Strong organizational and record keeping skills.
• Strong attention to detail and analytical skills.
• Ability to work effectively within a team and independently.
• Proficient in Microsoft software applications: Excel, Word, PowerPoint, and Outlook.
• Proficient in ERP software applications.
• Proficient in QMS software applications.
• Excellent organizational skills.

Nice To Haves

• Four-year college degree or equivalent Quality experience.

Responsibilities

• Responsible for the review of executed Batch Records for in-process and final products, and associate documentation for compliance with cGMPs and compliance with all BTHI policies and procedures.
• Responsible to assess acceptability for product final release to distribution.
• Responsible for the Disposition of Finished Goods.
• Collaborate, work closely with manufacturing, distribution, product development, engineering, and other relevant teams to coordinate the timely and smooth release of products.
• Execute containment of all material impacted by on-going investigations.
• Responsible for the review of Micro testing results for Bioburden test and Environmental Monitoring.
• Responsible for the physical and electronic movement of product from quarantine and release locations.
• Conduct periodic cycle counts Inventory for physical and electronic reconciliation.
• Serve as the liaison with laboratories to ensure that results are obtained in a timely manner for donor testing as well as Environmental Monitoring test results.
• Responsible for training new staff members, cross-training between departments, and performing competency checks.
• Assists in the development and review of SOPs, WI, Forms and Batch Records as required for compliance with cGMPs, Standards and Regulations, and consistency with other BTHI policies and procedures.
• Provides batch record updates to the BTHI management team regarding pending releases and potential delays.
• Participate in continuous improvement initiatives by suggesting process enhancements based on testing feedback and product release outcomes.
• Responsible for performing administrative duties in the GMP environment including, but not limited to filing, copying, scanning, shredding or archiving GMP documents for the Quality department as needed.
• Performs other duties as assigned.

What This Job Offers

• Education Level: High school or GED