Quality Systems Specialist 1st Shift

QuVa Pharma, Inc.; Sugar Land (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

QuVa Pharma, Inc. is seeking a Quality Systems Specialist to ensure high quality and safety standards for pharmaceutical products.

You will maintain and coordinate quality system documents for cGMP compliance, process changes in batch records through Change Control, and issue up-to-date procedures, forms, and batch records with minimal supervision. The role is full-time on-site at Sugar Land, TX, with a set Monday–Friday schedule, and involves working on a robust quality management framework

Qualifications

• High school diploma or GED is required.
• 1+ year of experience is preferred; 6 months to 1 year at Quva Pharma is noted.
• Understanding of archival processes and document controls is preferred.
• Must be 18+ years of age.
• Must pass drug and background checks.
• Authorized to work in the United States on a full-time basis; visa sponsorship is not available.
• Experience in FDA-regulated operations or GMP-related environments is a plus.

Responsibilities

• Review and write document change requests.
• Coordinate updates to procedures, forms and batch records across departments.
• Maintain quality management systems and document workflows.
• Generate workflows for document creation, revision and implementation.
• Ensure documents have current version at all times.
• Assist with audits by retrieving documents and information.
• Coordinate procedure effective dates with training department.
• Act as administrator of controlled documents for Quality functions.
• Participate in process improvements and projects.

Skills

Attention to detail

Verbal and written communication

Education

High school diploma or GED

Bachelor’s Degree in life science

Tools

Microsoft Office

Adobe

Word

Excel

Job description

TX - SL West Airport
12620 W Airport Blvd
Sugar Land, TX 77478, USA

Description

Our Quality Systems 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 maintaining and coordinating Quality Systems related documents for compliance with cGMP and company procedures with minimal supervision. This person will process changes in controlled batch records via Change Control process; issue effective documents including procedures, forms and batch records, and process changes to the procedures. 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 1st shift, working Monday through Friday from 7:00 AM - 4:00PM. This is a set, consistent schedule with minimum overtime requirements and 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. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

What the Quality Systems Specialist Does Each Day:

• Review and write document change requests
• Interact with other departments to address required updates to procedure, forms and/or batch records
• Maintain all quality management systems
• Generate workflows for creation, revisions, review, approval and implementation of procedures, form, batch records
• Ensure documents have the most current and up to date version at all times
• Review documents for compliance with company standards for formatting, review, approvals and implementation
• Perform gap analysis of all quality related procedures to ensure there are no gaps present
• Maintain procedures for document workflow, document retention, archiving and retrieval
• Assist with document retrieval during audits
• Coordinate assignment of procedures effective dates with training department
• Act as administrator of controlled documents used for Quality functions
• Participate in process improvements and projects within the company

Our Most Successful Quality Systems Specialists:

• Understand how to update Standard Operating Procedures, with documentation of summary of changes and version control
• Are proficient in Microsoft Office, Adobe, Word, and Excel
• Have strong attention to detail and the ability to identify and elevate complex situations
• Detail-oriented with strong verbal and written communications skills

Minimum Requirements for this Role:

• High school diploma or GED from recognized institution or organization required
• At least 6 months to 1 years’ experience at Quva Pharma
• Understanding of archival process, preferred experience in document storage and controls
• 18+ years of age
• Able to successfully complete a drug and background check
• 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
• Understanding of archival process, preferred experience in document storage and controls

Any of the Following Will Give You an Edge:

• 1 to 2 years’ experience with FDA-regulated operations (cGMP processes)
• 1 to 2 years’ experience in Quality Assurance, Sterile Compounding and/or GMP production facility
• Bachelor’s Degree in life science or related field

Benefits of Working at Quva:

• 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
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

About Quva:

Quva is a national, industry-leading provider of compounded injectable medicinesand 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 BrightStreampartners with health-systems to analyze large amounts of data and through AI and machine learning,develops softwaresolutions 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."

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.