Aerotek QA Specialist in Cambridge, Massachusetts
The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.
This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving, final product packaging/release to the courier, customer complaint audits, write and/or revise standard operating procedures
Master core responsibilities of Specialist I.
Maintaining and adhering to compliance requirements for established quality systems programs.
Identify issues, provide recommendations as well as executing compliance improvements.
Participate in mid-scale projects or assignments.
Address and/or escalate compliance problems and issues.
Interact with project teams and applicable research groups as they impact the quality operation.
Product complaints: independently receive, review, audit accompanying patient file, and send to Customer Care.
Independently initiate QA deviations and perform investigations, including determining root cause and planning corrective actions.
Support the training of specialist I’s.
Other duties as assigned.
Quality assurance, Gmp, Batch record, Batch record review, deviation, biologics, capa, investigations, medical device, pharmaceutical
Top Skills Details:
Batch Record Review
Additional Skills & Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
High School Diploma plus 3+ years of related experience in Quality Assurance.
Basic knowledge of GMP regulations
Strong written and verbal communication skills
Strong organization and time management skills
Experience with Electronic Quality Management Systems (Trackwise)
Proficient in MS Word, Excel, and PowerPoint
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.
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