Supervisor, Quality Assurance 3rd Shift

QuVa Pharma; Sugar Land (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health and wellness benefits

401k with match

Paid time off

Overtime opportunities with notice

Career advancement opportunities

Job summary

Quva seeks a Supervisor, Quality Assurance to lead QA on assigned shift, ensure compliance with FDA 503B and cGMP, and supervise QA staff throughout operations. You will oversee investigations, corrective actions, environmental monitoring, and disposition of finished products to meet specifications.

You will maintain QA records, calibrate testing equipment, develop QA policies, and communicate with Operations on product issues.

Qualifications

• High School diploma or equivalent required.
• Successful completion of drug and background check.
• 1 year of supervisory or management experience.
• 2 years' experience in Quality Assurance / cGMP / FDA regulated industry.
• Physical ability to lift up to 50 lbs., with or without accommodation.
• Must be authorized to work in the United States; no visa sponsorship.

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.

Skills

QA supervision

cGMP knowledge

FDA regulated industry

Attention to detail

Education

High School diploma or equivalent

Bachelor's Degree in Life Science

Tools

QA documentation tools

Job description

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

Minimum Requirements for this Role:

• 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

Any of the Following Will Give You an Edge:

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

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
• 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

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality 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. 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".

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