* This position is primarily responsible for supporting the maintenance of quality systems and processes to assure GMP compliance for relevant operations carried out, including activities related to preclinical and clinical supplies and commercial production.
Job Description and responsibilities:
* Perform quality reviews for maintenance work orders and instrument calibration assessments. Review equipment cycle and monitoring data to ensure proper operation.
* Perform final review of room, equipment, and facility records and associated support systems to release areas for cGMP operations.
* Perform review of documentation to determine release status of materials, components, and final product. Approve items for release or non-conformance investigation.
* Approve the mechanism for isolating and/or quarantining equipment, facilities, or materials that fail to meet required specifications.
* Conduct review of batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records.
* Lead investigations, when assigned, to allow for disposition of material and approve return-to-use for quarantine materials or return-to-service orders for equipment and facilities following completion of investigations.
* Develop, implement and maintain quality documentation, including equipment master files, personnel training files, controlled material files, and document control files.
* Other responsibilities as required
* 1+ years' quality assurance experience in the medical device industry.
* Experience in the review of incoming inspection records, batch production records and supporting batch documentation, such as quality control testing data and equipment maintenance and calibration records..
* Demonstrated proficiency with Quality System procedures and Medical Device Directives, 21 CFR 820 and ISO 13485, and related international standards.
* Bachelor's degree from an accredited college or university, preferably in life sciences, engineering, scientific or technical discipline.
* Ability to work effectively in a team environment and on cross-functional teams.
* Ability to effectively manage multiple competing priorities.
* Prior start up or small company experience and accomplishments preferred.
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.Aerotek is acting as an Employment Agency in relation to this vacancy.