Lead Quality Assurance Specialist 2nd Shift

QuVa Pharma•Sugar Land, TX

36d•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.

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
Are detail-oriented with strong verbal and written communications skills

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

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