Entry-level quality assurance specialist having a BA/BS in a scientific field of study with with 3-5 years of experience working in a cGMP environment (pharma / biopharma preferred), with proven experience in Quality Systems or Quality Operations management.
- Hands-on experience with quality management system (i.e. training, metrics, documentation management)
- Robust understanding of change control work flow
- Strong background on Deviations, Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) management
- Familiarity with documentation control practices, including writing and revision of policies, SOPs and work instructions
- Batch records review and approval for clinical and commercial products
- Compliance review experience (i.e. laboratory data review, product release)
- Aptitude for increasing efficiencies and improving processes
- Strong self-management skills
- Ability and expertise to work in a team setting
- Excellent communication skills
- Experience with GMP product manufacturing
- Experience with SOP adherence and tracking
- Ability to become familiar with technical procedures that are reflective of manufacturing operations/practices
- Experience with QMS and/or EDMS software preferred(i.e. Trackwise, MasterControl, Veeva Vault, etc.)
- BA/BS in a scientific field of study
- Responsible for verifying manufacturing and laboratory processes and tasks are completed appropriately and that data is entered in accordance with standards.
PharmaLex (previously Complya) is a dynamic, rapidly-growing Life Sciences Consulting firm that provides Quality Assurance and Regulatory Affairs consulting support to companies in the biotechnology, pharmaceutical and medical device sectors. Complya started in 2007 and has grown to an active team of nearly 60 consultants with an extended network of dozens of consultants located in strategic cities throughout the United States, Europe, and Asia. Through a recent strategic merger with PharmaLex (a leading specialist provider of scientific affairs, regulatory affairs, pharmacovigilance and development consulting) Complya is now able to expand its reach and draw upon a deeper bench of resources in order to offer valuable new services to our clients in Boston and beyond.
PharmaLex is the largest global service provider of regulatory affairs, quality management and compliance, pharmacovigilance and development consulting, in the pharmaceutical and medical device industry. We specialize in effectively supporting all aspects of product development – ranging from early development and market entry to product maintenance activities. The success of our company resides in the expert knowledge and high motivation of our employees.
Role: Quality Assurance Consultant (Pharma/Biotech) - Maryland
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