QA SPECIALIST (QA-005)

General Job Description/Team Overview:

This position is located within the Quality Assurance department and is responsible for the quality support functions associated with the manufacturing, testing, and distribution of investigational drug products. The qualified candidate will ensure compliance with cGMP, GDP, GLP, and company procedures. The position will support daily manufacturing and facility operations; perform general QA work; identify and make recommendations for improvements as part of a team within or outside the department to ensure continuous improvement; work on problems of a diverse scope where analysis and problem solving are required. The level will be determined based upon the candidate’s education, skills, and/or related experience.

Primary Duties and Responsibilities (include but are not limited to):

1. Manufacturing/ Facilities/ Quality Control support

· Disposition of incoming raw materials.

· On the floor manufacturing support; communicate and resolve discrepancies with manufacturing operators or supervisors; provide cGMP training and coaching to manufacturing staff as needed.

· Act as QA subject matter expert (SME) and support/train staff as needed on root cause analysis and development of corresponding corrective and preventive actions.

· Oversee manufacturing operations during drug product labeling and packaging.

· Maintain master equipment list and files; review records of preventive maintenance and calibration of equipment.

· Review analytical and stability data, as needed.

2. Document control

· Author and/or revise SOPs; authority to approve written procedures and other documents.

· Process change requests, issue-controlled documents including but not limited to satellite copies, batch records, forms, and databooks.

3. Deviation management

· Manage the deviation tracking log to ensure timely completion and closure of deviation reports.

· Initiate deviations for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.

· Author and/or review investigation reports ensuring adequate resolution and compliance with cGMP.

· Assist in investigations for deviations by supporting data gathering and root cause analysis.

4. Product disposition

· Manage batch disposition process by ensuring that all required documents and records are accurately and properly completed, including all batch-related deviations, to ensure timely shipment of the final product.

· Review of executed batch records, test results, and certificates of analysis to ensure compliance with approved procedures.

· Resolve all issues prior to release of product.

5. Internal audit

· Schedule, plan, and prepare for internal audits of manufacturing, facilities, and quality control laboratory to assess compliance to cGMP, applicable regulations, and written procedures.

· Perform routine self-inspections of the quality system.

· Lead and conduct internal audits; document observations; make recommendations for improvement; oversee implementation of corresponding CAPAs; monitor the effectiveness of the improvements.

6. Supplier quality management

· Manage the supplier qualification program. 

· Create and manage risk-based processes and inspection programs that can support GenVivo’s supply chain. Develop and manage risk-based audit schedule; including prioritization to support strategic initiatives.

· Collaborate with internal partners to qualify and onboard new vendors and/or service providers.

7. Perform other duties as assigned.

Required Qualifications:

· Bachelor’s degree in a scientific discipline or equivalent (additional experience may be considered in lieu of education).

· 3+ years of biopharmaceutical or pharmaceutical FDA regulated industry experience working in QA. 

· In-depth comprehension of quality and cGMP principles; along with general knowledge of Federal and State regulatory requirements in a GxP environment.

· Experience in administration and/or development of quality systems for startup drug product manufacturing and quality unit operations.

· Committed to quality and continuous improvement.

· Experience in performing and reporting investigations.

· Ability to manage multiple simultaneous priorities in a high-volume environment. 

· Sound decision-making, technical and problem-solving abilities with demonstrated initiative and interpersonal skills.

· Innovative, proactive, and resourceful. 

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with strong attention to detail and accurate record keeping.

· Successful professional with good work ethic (including but not limited to dependability and punctuality) and a high degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal communication skills.

· Eligible to work in the U.S.

Compensation Range: $85,000-$125,000

Job Type: Full-time