Job description

Job Title: Quality & Compliance Specialist

Duration: 6+ months contract

Location: Devens, MA

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 BMS 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 discipline

· Minimum of 3 years Quality experience in the biopharmaceutical industry

· A thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.

· Excellent written and verbal communication skills

· Ability to work on their own initiative in addition to working as part of a team

· Ability to work across a team matrix in order to meet accelerated timelines

· Excellent time management & organisational skills along with a proven ability to multi-task.

Job Types: Full-time, Contract

Salary: $40.00 - $45.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• CGMP: 4 years (Required)
• Quality control: 3 years (Required)
• laboratory compliance: 3 years (Required)

Work Location: One location

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