Lead Quality Assurance Specialist - 2nd Shift

Quva • Sugar Land, TX

8d • Onsite

About The Position

Our Lead Quality Assurance Specialist 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 oversight and performance of functional areas, and training in regard to processes and documentation as they pertain to quality standards and governmental regulations. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 10:30 PM. This is a set, consistent schedule 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 Lead Quality Assurance Specialist Does Each Day: Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS) Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function Works 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 Supports department supervision in oversight and prioritization of day-to-day responsibilities. Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes Provides an established technical expertise for current processes and oversees training of department personnel on new processes Maintenance of retained sample storage Reviews 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 Review and approval of shipping documentation for commercial products Our Most Successful Lead Quality Assurance Specialists: Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility Are detail-oriented with strong verbal and written communications skills Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

Requirements

• 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

Nice To Haves

• Bachelor’s Degree in life science or related field preferred but not required
• At least 1 year experience at Quva Pharma preferred
• At least 2 years’ experience with FDA-regulated operations (cGMP processes) preferred

Responsibilities

• Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Follows all regulatory guidelines, cGMP guidelines, and aseptic techniques as required by the job function
• Works 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
• Supports department supervision in oversight and prioritization of day-to-day responsibilities.
• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
• Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Provides an established technical expertise for current processes and oversees training of department personnel on new processes
• Maintenance of retained sample storage
• Reviews 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
• Review and approval of shipping documentation for commercial products
• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
• Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions
• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
• Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 251-500 employees