Quality Control / Quality Assurance Specialist

This is a hybrid role, and is primarily work-from-home, however primary residence local to Richmond, VA is preferred. 

As a Quality Control / Quality Assurance Specialist you will:

• Participate actively and serve as a member of cross-functional product development team(s).
• Prepare Statements of Work (SOW) and Purchase Orders (PO) with suppliers.
• Track and review supplier invoices for management approval.
• Compile and analyze data for development of testing strategies and protocols to validate product performance and safety before market release.
• Based on data and industry standard, make recommendations for establishing and maintain effective quality control measures throughout the manufacturing process.
• Collect and scrutinize quality data to identify trends, issues, and opportunities for improvement, as well as preparing reports for stakeholders.
• Serve as the day-to-day contact with vendors, escalating issues and quality events to Kaleo Quality Management and generating and tracking to completion the appropriate record in MasterControl such as quality event, out of specification (OOS), out of trend (OOT), or change request.
• Complete action items and other process records in MasterControl as assigned.
• Collation and preparation of data structures to support trending of critical batch release information, in-process testing, and stability program metrics.
• Identify trends, report negative trends to supervisor and to the Quality Management System (QMS), participating in root cause analysis as part of a cross-functional team, and executing corrective actions and preventative actions (CAPA) as assigned.
• Execute data mining initiatives to meet quarterly key performance indicator (KPI) assessments and management reviews.
• Compile data to facilitate management approval of Alert Limits, including providing an initial proposal based on the assessment and generating the final report for management approval.
• Supporting Regulatory filings by maintaining associated stability tables for Annual Reports and critical changes requiring CBE 0, CBE 30, or PAS.
• Monitor manufacturing schedules and production release forecasts to facilitate timely shipping and release to market of finished product.
• Receive approved executed batch records from contract manufacturing partner (CMO) and conduct a final comparison of critical quality attributes and critical process parameters to the. approved specification and generate the applicable certificates for final approval and issuance by Kaleo’s Production Manager.
• During back-to-school season and other times of high volume, participate in the acceptance, investigation approval, and closure of product complaints, as assigned.
• Facilitate the review and revision process and workflow for management approval assigned controlled documents (SOPs, Work Instructions, Specifications, Agreements, etc.).
• Participate in, and facilitate as assigned, Annual Product Quality Reviews (APQR) for cross-functional management approval.

A successful Quality Control / Quality Assurance Specialist will have:

• The ability to manage multiple priorities/projects and work in a fast paced and flexible environment.
• The ability to communicate effectively internally, externally, and across different levels of the organization.
• The ability to partner effectively with external laboratory and manufacturing partners.
• A strong understanding of data analysis tools and root cause analysis.
• Strong oral and written communication skills with the ability to articulate technical information concisely.
• A commitment to fostering an inclusive workplace.

To be considered for the position, you must have:

• Degree in the life sciences or equivalent experience.
• 1+ years’ experience working in a GMP laboratory and/or stability program management.
• Understanding of Current Good Manufacturing Practices (CGMPs), United States Food & Drug Administration (FDA) and International Council for Harmonisation (ICH) guidance documents related to Stability and data integrity
• Experience with Microsoft Applications such as Word, Excel, PowerPoint, Teams, and SharePoint.
• Willingness to obtain industry relevant certification within 2 years of hire, such as ASQ CQIA or CQPA.