Posted on: April 9, 2021
Hi everyone! Please see below for an incredible opportunity as a
QA Specialist II at a growing company: Description:Department
Description: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. Position Summary: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 proceduresCore
- 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
- 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
- Support the training of Specialist I's.
- Other duties as assigned.Skills:Quality assurance, Gmp, Batch
record, Batch record review, deviation, biologics, capa,
investigations, medical device, pharmaceuticalTop Skills Details:
- Batch Record Review
- DeviationsAdditional Skills & Qualifications:Leadership
- 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
- 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.Basic Qualifications:High
School Diploma plus 3+ years of related experience in Quality
Assurance.Basic knowledge of GMP regulationsBatch Record
ReviewPreferred Qualifications:Strong written and verbal
communication skillsStrong organization and time management
skillsExperience with Electronic Quality Management Systems
(Trackwise)Proficient in MS Word, Excel, and PowerPointPlease apply
if interested and reach out with any questions! About Aerotek: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.
Keywords: Aerotek, Cambridge , QA Specialist, Other , Cambridge, Massachusetts
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