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Company Contact Info
- Lincoln, RI
- Alex Miller
- Phone: 4012281273
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Sr. Quality Operations Specialist
Aerotek • Lincoln, RI
Posted 29 days ago
* Reviews manufacturing and support records to certify compliance with specifications and procedures.
* Makes recommendation to Quality Assurance Management for the release of product based on Quality Assurance record review and approval.
* Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues.
* Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
* Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
* Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems
* Representing Quality Assurance at various project and technical meetings, as needed
* Working with all departments to ensure timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions
* Inputting information from the Quality Systems into electronic databases and generating reports from these systems
* Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times.
* Providing on the floor support to Manufacturing
* Reviewing Manufacturing batch records and completing required documentation for batch disposition
* Document creation and review, including Standard Operating Procedures, protocols, and reports
* Performing Internal Audits and Data Audits, as needed.
* Providing training to site personnel and contractors on GMP and the Quality System procedures
* Bachelor's degree in Life Sciences, or related field or with 5 to 8 years' experience in biopharmaceutical/pharmaceutical or related industry with at least 3 years direct quality experience
* Excellent written and verbal communication and negotiating skills
* Experience with a cell therapy product is preferred
* Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment
* Ability to monitor and report on assigned tasks, goals and objectives
* Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors
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 888-237-6835 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.