Supervisor, Quality Assurance 2nd Shift

Quva • Bloomsbury, NJ

17d

About The Position

Our Supervisor, Quality Assurance 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 supervising all Quality Assurance (QA) aspects of compounding pharmaceuticals for compliance within the facility. This position operates within the legal and regulatory compliance, producing a quality product. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. What the Supervisor, Quality Assurance Does Each Day: Supervises Quality Assurance staff on assigned shift Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions 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. Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release Periodically review records to verify that quality standards for each drug product is met Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws Responsible for maintaining QA records associated with internal and external testing Responsible to maintain all testing equipment in compliance, calibration, and certification Assists in developing policies and procedures related to QA Promptly communicates with Operations regarding complaints, product issues/variance Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation Enforces applicable personnel policies and procedures Our Most Successful Supervisor, Quality Assurance: Are detail-oriented with strong verbal and written communications skills Express energy, show accountability, and multi-task Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels Have good interpersonal skills and the ability to work effectively and efficiently in a team environment to accomplish goals

Requirements

• A High School diploma or equivalent
• Able to successfully complete a drug and background check
• 1 year of supervisory or management experience required
• 2 years’ experience in Quality Assurance / cGMP / FDA regulated industry
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
• Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas

Nice To Haves

• Bachelor’s Degree in Life Science or other related field

Responsibilities

• Supervises Quality Assurance staff on assigned shift
• Oversees failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions
• 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.
• Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Responsible for maintaining QA records associated with internal and external testing
• Responsible to maintain all testing equipment in compliance, calibration, and certification
• Assists in developing policies and procedures related to QA
• Promptly communicates with Operations regarding complaints, product issues/variance
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforces applicable personnel policies and procedures

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED