Quality Assurance Specialist - Shipping Center

QuvaSugar Land, TX
1dOnsite

About The Position

Our Quality Assurance Specialist – Shipping Center is responsible for the receipt and inspection of all finished products from Quva’s manufacturing sites and for all quality processes associated with the incoming and outgoing shipments associated. This role requires critical thinking and authority to proactively address and/or escalate all quality issues. The Quality Assurance Specialist performs basic QA functions related to verification of incoming and outgoing finish products. 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 working Monday through Friday 10:00 AM to 7:00 PM. 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.

Requirements

  • A High School diploma or equivalent; Bachelor’s Degree in life science or equivalent work experience preferred
  • 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
  • 2+ years’ experience in FDA regulated Quality Assurance, and/or GMP production facility required
  • 2+ years’ experience in a warehouse or shipping center
  • 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

  • Strong knowledge of MS Office (Excel, Word, Outlook & PowerPoint)
  • Basic understanding of accounting concepts
  • Understanding in updating Standard Operating Procedure, with documentation of summary of changes and version control
  • Ability to manage projects coordinating cross-departmental activities
  • Proficient in Microsoft Office, Adobe, Word and Excel
  • Detail-oriented with strong verbal and written communications skills

Responsibilities

  • Dispositions steps in ERP system
  • Assesses critical data on released items in ERP system
  • Inspects of finished products from other QuVa sites
  • Assists with the coordination of product Quality inspects and dispositions in ERP of labels
  • Reviews shipping documentation
  • Quality review / verification of critical information related to the receipt of finished products
  • Escalates any discrepancies or non-conformances found during incoming receipt inspection
  • Ensures company compliance to QuVa Pharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS)
  • Reviews quality documents to verify that quality standards have been met (COA, COC)
  • Maintains compliance with DEA, FDA, 503B and cGMP guidelines / state and federal laws
  • Responsible for maintaining incoming quality records associated with release of CSP

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