Our team members create value at every touch point of the quality assurance (QA) lifecycle. We believe in what we do and are looking for talented individuals who share that same passion for making a difference in the world. At Quality Assurance Consultancy, we offer flexible and competitive benefit programs.
If you’re looking for an exciting career opportunity in the life sciences field, don’t delay any longer.

QUALITY ASSURANCE SENIOR CONSULTANT

At Quality Assurance Consultancy, we are currently seeking an experienced individual to become a critical member of our specialized, dedicated QA team—reporting directly to the managing Director of Quality Assurance Consultancy at our Maryland-based headquarters. For this salaried, full-time position, you need to have extensive knowledge of GLPs (EPA, FDA, OECD) and GCPs (FDA/ICH). FDA Good Manufacturing Practices (GMP) experience will be considered a plus, as well as any other related regulations and guidelines. You also will need to be able to travel (local, US and potentially international) to interact with customers, attend conferences and conduct project-specific work at customer locations.

About Background Requirements

  • Bachelor’s degree in the life sciences
  • Minimum of five years of experience in a regulated environment performing the functions of a quality assurance professional
  • Excellent writing and communication skills
  • Ability to work both independently and within a team setting

About Job Responsibilities

  • Conduct study audits to ensure compliance with applicable regulations, such as: GLPs, GCPs or GMPs.
  • Audit protocols, raw data, reports, batch records and other supporting documentation for accuracy, consistency and conformance with regulations and customer internal Standard Operating Procedures (SOPs).
  • Perform phase inspections of ongoing studies at customer designated sites.
  • Write and review/edit customer SOPs and data forms.
  • Assess previous audit findings to establish customer priorities and strategies.
  • Perform qualification audits at customer designated sites. This includes conducting non-clinical laboratories, clinical sites, clinical CROs, field research facilities, vendors, etc.
  • Audit computer and equipment system validations.
  • Develop and maintain customer relationships.
  • Present GLP, GCP and GMP training sessions.
  • Provide training, guidance and coaching to team members.

About US

Quality Assurance Consultancy, a division of Quality Associates Inc. (QAI), is a leading provider of GxP quality assurance (QA), scientific support and archiving solutions. Since 1986, we have been assisting universities and companies in the pharmaceutical and agrochemical industries to reduce the time and expense of meeting critical internal and regulatory requirements—providing support for FDA, EPA and OECD GLPs, FDA/ICH GCP and FDA VICH GCP regulations and guidelines. QAI is a subsidiary of Konica Minolta (www.konicaminolta.us) and offers competitive salaries and excellent benefits. QAI is an Equal Opportunities Employer and does not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. For more details on Quality Assurance Consultancy, please visit our web site at www.QualityAssociatesQA.com. Our corporate office is conveniently located near three major airports and is less than one hour by car from downtown Washington, D.C. and Baltimore, MD.

Don’t Delay

If you’re looking for an exciting career in the life sciences field, please send your resume/CV directly to: Daniel Carey at dcarey@qualityassociatesQA.com.