Quality Systems Specialist 1st Shift

Our Quality Systems Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include maintaining and coordinating Quality Systems related documents for compliance with cGMP and company procedures with minimal supervision. This person will process changes in controlled batch records via Change Control process; issue effective documents including procedures, forms and batch records, and process changes to the procedures.

Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 1st shift, working Monday through Friday from 7:00 AM - 4:00PM.

This is a set, consistent schedule with minimum overtime requirements and based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

• Review and write document change requests
• Interact with other departments to address required updates to procedure, forms and/or batch records
• Maintain all quality management systems
• Generate workflows for creation, revisions, review, approval and implementation of procedures, form, batch records
• Ensure documents have the most current and up to date version at all times
• Review documents for compliance with company standards for formatting, review, approvals and implementation
• Perform gap analysis of all quality related procedures to ensure there are no gaps present
• Maintain procedures for document workflow, document retention, archiving and retrieval
• Assist with document retrieval during audits
• Coordinate assignment of procedures effective dates with training department
• Act as administrator of controlled documents used for Quality functions
• Participate in process improvements and projects within the company

• Understand how to update Standard Operating Procedures, with documentation of summary of changes and version control
• Are proficient in Microsoft Office, Adobe, Word, and Excel
• Have strong attention to detail and the ability to identify and escalation complex situations
• Detail-oriented with strong verbal and written communications skills

• High school diploma or GED from recognized institution or organization required
• At least 6 months to 1 years’ experience at Quva Pharma
• Understanding of archival process, preferred experience in document storage and controls
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis;
  Quva is not able to sponsor applicants for work visas
• Understanding of archival process, preferred experience in document storage and controls

• 1 to 2 years’ experience with FDA-regulated operations (cGMP processes)
• 1 to 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility
• Bachelor’s Degree in life science or related field

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime…