Summary
A well-known leader in the biopharmaceutical industry is seeking a seasoned professional to join their team as a Sr. Quality Assurance Specialist in Baltimore, Maryland. You will be responsible for providing input on quality control procedures, oversight on quality processes, systems, procedures, and programs. Your duties will also include performing batch/lot record reviews, and reviewing disposition decisions for the client's commercial products. The Sr. Quality Assurance Associate will also need to work independently from management to ensure organizational, site, and departmental goals are achieved. This role is a minimum 11 month contract with possibilities for extension.
Your responsibilities would include:
- Ensuring commercial product records are following all GMP's and SOPs
- Performance of batch record reviews
- Assess, write, and conduct risk assessments for deviations and investigations in order to fully get the scope and impact of any deviation; discovering the cause and assigning the correct CAPA
- Handling of product complaints, from contacting customers, conducting investigations, and assigning the appropriate CAPA
- Draft investigation reports, SOPs, and other QA documentations
Your qualifications for this role will include:
- 8+ years of experience in commercial pharmaceutical Quality Assurance
- BA/BS or MS in Chemistry or a related field
- Experience with batch record reviews
- In depth knowledge of CGMPs in quality or manufacturing
- Excellent oral and written communication skills
- Attention to detail
- Ability to hold strong interpersonal relationships
- Strong critical thinking and organizational skills
- Knowledge of Trackwise is desirable
Competitive pay, full benefits, and an excellent chance to work with a prestigious company in biotherapeutics.
