If you’re looking for an exciting career opportunity in the life sciences field, don’t delay any longer.
QUALITY ASSURANCE SENIOR CONSULTANTAt 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.