As the Quality Systems Specialist 1, you will execute, maintain, and continually evaluate quality assurance functionalities, specifically document control, batch record review, and training. You will support deviation, CAPA, change control, audit, supplier quality, and batch release.

• Maintains the document control system including, but not limited to executing document revisions, managing document workflow in the electronic document system, and maintaining document retention.
• Maintains site training database, which includes entering new training items in system, maintaining curricula, and monitoring and reporting.
• Creation, issuance, review, and maintenance of batch records.
• Executes, maintains, and continually evaluates quality assurance methods and systems and utilizes standards and procedures to provide quality guidance and methods.
• Supports the Supplier Quality Management (SQM) system. 
• Supports Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule.
• Assists validation by reviewing protocols, execution of protocols, reviewing / writing of final reports.
• Provides monthly quality indicators and improves results.
• Applies the requirements fixed in the Quality Assurance and ensure that the procedures are followed.
• Participates in customer audits.
• Ensures that the ISO, cGMP, USDA guidelines and corporate policies are followed.

Who You are:

Minimum Qualifications

• Bachelor’s degree in a Scientific discipline (e.g., Biology, Chemistry, Microbiology, etc), or a quality discipline (e.g., Quality Assurance, Regulatory Affairs, etc.).
• 3 years’ experience in a Quality environment.

Preferred Qualifications

• 5 years progressive responsibility and experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance position.
• Project management experience.
• Experience in development and management of CAPA, Change Control, and document control systems and internal/ external audit processes.
• Expertise in cGMPs, FDA regulations, and SOP development.
• Basic computer skills and a working knowledge of basic (Microsoft Office (Word, Excel, PowerPoint, etc.) and MiniTab.
• Six Sigma training/certification.
• Strong verbal and written communication skills including the ability to conduct verbal presentations.
• Certified Quality Auditor (CQA).