Lead Quality Assurance Specialist 2nd Shift

What Lead Quality Assurance Specialist Does Each Day

• Oversight and performance of functional areas
• Training in regard to processes and documentation as they pertain to quality standards and governmental regulations
• Ensuring company compliance to Quva Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Following all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
• Working in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, and product distribution as applicable
• Supporting department supervision in oversight and prioritization of day-to-day responsibilities
• Ensuring all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
• Demonstrating a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Maintaining retained sample storage
• Reviewing routine manufacturing, environmental monitoring and quality control data for in-process and finished products
• Evaluation of batches / product for compliance with defined specifications
• Sampling, inspection, and control of commercial product labels
• Reviewing and approving shipping documentation for commercial products

Minimum Requirements For This Role

• A High School diploma or equivalent
• Able to successfully complete a drug and background check
• 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
• 20/20 vision (with or without corrective lenses) and the ability to successfully pass a color vision test
• Demonstrated performance with direct supervision of a team is required
• At least 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred
• Strong Microsoft Word and Excel skills
• 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
• 17 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

About Quva

Quva is a national, industry-leading provider of compounded injectable medicines and software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStream partners with health-systems to analyze large amounts of data and through AI and machine learning, develops software solutions that turn the data into insights that are used to better run their pharmacy operation. Quva’s overall product and technology offerings help health-systems achieve greater value and deliver the 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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