The Quality Assurance Specialist will be responsible for the routine quality review of one or more of MNTA's clinical or commercial products. The focus of this review of GMP biologics documentation including batch record review for compliance in support of product release.
Reporting into the Director of Quality, the QA Contractor will work with and guide MNTA's CMO Partners while working in collaboration with MNTA's Quality, CMC and other various groups.
BS in a scientific discipline with a minimum of 4+ years' quality experience in the pharmaceutical or biotechnology industry.
Strong understanding of biologics (cell culture processes) investigations, process and analytical qualification and validation, change controls and disposition.
Experience reviewing cell culture, drug product, buffers & media executed process batch records, analytical qualification protocols and reports, test procedures and specification.
Strong knowledge of FDA/ EMA guidelines and regulations, quality systems and GMP procedures.
Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision.
Must be flexible, and able to work in a small, fast-paced, dynamic, environment.
Ideal candidate will have strong experience in the following:
batch record reviewing, environmental monitoring background, previous QC/QA industry experience, understanding of drug substance and manufacturing
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing? Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-###-#### or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position. ?PandoLogic. Keywords: Quality Control / Quality Assurance Specialist, Location: Cambridge, MA - 02238 Associated topics: performance test, prevention, qa, quality assurance, quality assurance lead, software quality, software quality engineer, software quality assurance engineer, test engineer, tester
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.