- Review licensing requirements and develop strategies to meet regulatory obligations
- Verify all licenses match the required criteria while onboarding new customers
- Verify data and profile set up in INFOR comply with federal and state requirements for 503B industry
- Maintain and update customer licenses via customer portal submission
- Conduct regular internal reviews to ensure ongoing compliance with licensing requirements
- Prepare reports and documentation as required by regulatory agencies or internal stakeholders
- Provide accurate and timely updates on licensing status, changes, and compliance matters
- Continuously assess, enhance efficiency, improve licensing processes, and ensure adherence to best practices
- Performs the investigation and research that fall within Pharmacy Services for licensing related issues
- Writing and reviewing standard operating procedures related to Pharmacy Services
- Identify and address any potential compliance gaps or issues proactively
- Possess excellent problem-solving skills with the innate ability to recognize one's customer and to respond accordingly
- Stay updated on relevant laws, regulations, and industry standards to ensure compliance with 503B, DEA, BOP, DHHS, FDA guidelines
- Identity areas for automation or technology solutions to optimize the licensing process
- Establish & maintain cooperative cross-functional relationships w/peers across all sites in Customer Service & Commercial Operations to meet corporate objectives
- Have strong attention to detail and ability to identify and escalate complex situations
- 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
- Texas Pharmacy Technician Registration
- Bachelor's degree in a relevant field, such as business administration, legal studies, or regulatory affairs
- Strong knowledge of licensing regulations, laws, and compliance requirements in the applicable industry
- Minimum 2 years' prior experience in cGMP / FDA regulated industry or Pharmacy
- Excellent technical writing and verbal/written communication skills
- Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution
- Excellent working knowledge of Pharmacy industry, GMP-related requirements, and FDA guidelines
- Experience in the pharmaceutical industry with a strong analytical and/or manufacturing background
- Ability to independently analyze and reconcile moderate to complex issues
- Proficient with computers and word processing software
- 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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Compliance Specialist - Sugar Land, United States - QuVa Pharma
Description
Our Compliance Specialist - Vendor & Customer Licensing is an active participant in managing and overseeing the license vetting process.
Once you complete our training, your responsibilities will include ensuring compliance with legal requirements, obtaining necessary licenses and permits from customers and vendors as applicable, and maintaining accurate records.
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.What the Compliance Specialist - Vendor & Customer Licensing - Does Each Day:
Minimum Requirements for this Role:
Benefits of Working at QuVa:
About QuVa:
QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care.
We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide.
As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.
As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.
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."
