Lead Quality Assurance Specialist - 2nd Shift

Lead Quality Assurance Specialist - 2nd Shift Sugar Land, TX Job Details Full-time 1 day ago Benefits Paid holidays Health insurance Dental insurance Vision insurance 401(k) matching Opportunities for advancement Qualifications Microsoft Word Microsoft Excel Pharmaceutical regulatory compliance Labeling Safety standards in production Performance management Patient safety High school diploma or GED Manufacturing standard operating procedures Manufacturing facility Team development Bachelor's degree Decision making Batch records Quality inspection Pharmaceutical plant experience Quality control operations Training & development Quality assurance within manufacturing Sterile laboratory techniques Senior level Leadership 2 years Team motivation (leadership skill) Compounding medications Transportation documentation for distribution operations Regulatory compliance management Overseeing training FDA regulations Full Job Description 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 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 Any of the Following Will Give You an

Edge:

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 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 turns 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."