Quality Assurance Specialist - Facilities Maintenance 3Rd 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 on-the-floor 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 real-time.  The on-the-floor 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 on-time delivery is a must to be successful in this role!

This is a full-time role for our 3rd Shift, working Monday through Friday from 10:00 PM to 6:30 AM. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ 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
• 18+ years of age
• 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

Benefits of Working at QuVa:

• Set, full-time, 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, industry-leading high growth company with future career advancement opportunities

About QuVa:

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

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. QuVa's 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.”