Quality Assurance Specialist - Facilities Maintenance 2nd Shift

Our Quality Assurance Specialist Facilities Maintenance 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 providing daily onthefloor support and oversight to all facility maintenance and engineering projects repairs work orders and processes within the pharmaceutical manufacturing facility. The oversight includes evaluation and review of ongoing facilities activities in realtime. The onthefloor quality team is responsible for making sure the process and documentation records are compliant with patient safety in mind executing with efficiency always. Quality safety and ontime delivery is a must to be successful in this role!

This is a fulltime role for our 2nd shift working Monday through Friday from 2:00 PM to 10:30 PM. 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.

What the Quality Assurance Specialist Facilities Maintenance Does Each Day:

• Reviews approves and ensures completion of all facility related work orders for the manufacturing site
• Ensures compliance with clean room standards during all facility related projects
• Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions related to facility / maintenance work orders processes and/or jobs performed
• Develops and provides oversight to identification and implementation of appropriate corrective actions and preventive actions
• Oversight of the environmental monitoring program including appropriate escalation of environmental and personnel monitoring results that exceed alert or action limits and interpreting results
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining Quality Assurance records associated with facilities or maintenance
• Responsible to maintain all testing equipment records in compliance calibration and certification
• Promptly escalates all discrepancies variances or issues

Our Most Successful Quality Assurance Specialist Facilities Maintenance:

• Have a strong attention to detail and carefully follows compounding protocols and all Standard Operating Procedures (SOPs) related to the job
• Are proactive and demonstrate initiative when appropriate; uses their time wisely
• Have a passion for connecting their work to a greater purpose
  
  

Minimum Requirements for this Role:

• Bachelor of Science Degree in a scientific discipline (or 4 years of technical manufacturing experience in lieu of degree)
• Able to successfully complete a drug and background check
• Minimum of 2 years related experience supporting compliance in regulated industry required or 3 years direct pharmaceutical experience in lieu of
• Experience with Maintenance Safety practices and protocols
• Knowledgeable in ISO 5/7 environment cleanroom gowning
• Knowledge of manufacturing processes procedures and basic facilities maintenance functions
• Able and willing to walk stoop stand bend and lift up to 50 lbs. throughout each shift with or without reasonable accommodation
• 18 years of age
• Must be currently authorized to work in the United States on a fulltime basis; Quva is not able to sponsor applicants for work visas

Benefits of Working at Quva:

• Set fulltime consistent work schedule
• Comprehensive health and wellness benefits including medical dental and vision
• 401k retirement program with company match
• A minimum of 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National industryleading high growth company with future career advancement opportunities

About Quva:

Quva is a national industryleading provider of compounded injectable medicinesand software solutions that help power the business of hospital and healthsystem pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStreampartners with healthsystems to analyze large amounts of data and through AI and machine learningdevelops softwaresolutions that turns the data into insights that are used to better run their pharmacy operation. Quvas overall product and technology offerings help healthsystems achieve greater value and deliver the highestquality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quvas Equal Opportunity Policy prohibits harassment or discrimination due to age ancestry color disability gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin race religious creed sex (including pregnancy childbirth breastfeeding and any related medical conditions) sexual orientation and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

Required Experience:

Unclear Seniority