Quality - Analytical Quality & Compliance Specialist

Sunrise System Inc. is currently looking for Analytical Quality & Compliance Specialist  in Devens, MA  with one of our top clients.  Job Title: Analytical Quality & Compliance SpecialistJob Id: (phone number removed)Location: Devens, MA 01434Duration: 12 monthsPosition Type: Hourly contract Position (W2 only)  Responsibilities will include:  Review and approve qualification documents (URS, DQ, IOQ & Summary Reports) in scope of Windows10 instrument upgrade project ensuring compliance with corporate policies, directives and current regulatory requirements for laboratory instruments, including Data Integrity requirements.Review and Approve qualification and CSV testing related to qualification and data integrity (DI) risks throughout the instrument qualification.Support NQC on the day to day activities associated with upgrading of instruments to operate with Windows10 software, developing plans and schedules with the NQC team to execute in order to meet project deliverables.Collaborating with IT business partners to develop software configurations in order to meet regulatory and Client Data Integrity requirements.Review and approve data migration solutions and testing plans for system upgrades to Windows 10 compatible software.Collaborate/liaise with cross functional teams, such as Network QC site QA, IT, and site QC instrument groups to ensure validation activities completed on schedule to ensure timely release for use in QC.Support the Network QC team in developing & implementing a strategy to standardize QC instruments (make/model/software) and data reporting in order to reduce Data Integrity (DI) risks. Qualifications and Experience required:Minimum of a BS in Chemistry, Biology or related disciplineMinimum of 3 years Quality experience in the biopharmaceutical industryA thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.Excellent written and verbal communication skillsAbility to work on their own initiative in addition to working as part of a teamAbility to work across a team matrix in order to meet accelerated timelinesExcellent time management & organisational skills along with a proven ability to multi-task.Candidate is expected to display the Client Biopharma Behaviors, which enables them to be successful and perform at their highest level:Passion: Our Dedication to learning and excellence helps us to deliver exceptional results.Innovation: We pursue disruptive and bold solutions for our patientsUrgency: We move together with speed and quality because patients are waitingAccountability: We all own Client success and strive to be transparent and deliver on our commitments.Integrity: We demonstrate ethics, integrity, and quality in everything we do for our patients, customers and colleagues. Inclusion:We embrace diversity and foster an environment where we can all work together at our full potential.   ContactAshith KumarDirect:(phone number removed)  |Email: (url removed)OrSatya | Delivery ManagerDirect:(phone number removed)|Email:(url removed)