Job Title: Quality Compliance Specialist

Location: Norwood, MA

Summary

This role is an exciting opportunity to be a part of the Quality Assurance organization for our client in Norwood, MA. As the company grows, the Quality Assurance Department is also growing and is looking for talented individuals with a strong Quality Culture and the ability to adapt to a fast-paced environment. This role will take the lead for many of the responsibilities listed below and will be expected to see tasks to completion successfully with minimal oversight.

Key Responsibilities

• Assist in improving and maintaining overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations.

• Lead site metric trending, including evaluation of trends and implementation of actions

• Manage the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.

• Partner with cross-functional teams to take action against metrics as needed.

• Partner with cross-functional teams to ensure actions on data trending are taken and improvements are driven as needed

• Drive process enhancements to gain efficiencies as they relate to Deviations and CAPAs

• Lead Deviation Review Board, Change Review Board and CAPA review board initiatives

• Work collaboratively with the digital team on the GXP-integrated digital landscape to support all electronic systems.

• Participate in internal audit program and third-party/regulatory inspection programs for the Norwood cGMP manufacturing facility.

• Maintain audit responses and audit trending.

• Participate in Management Review Meetings

• Perform Annual Product Reviews

• Additional duties as may be assigned from time to time

Skills & Qualifications

• BS degree with at least 4 years of Quality assurance experience in pharmaceutical industry providing Quality Assurance oversight OR 2 years of experience with MS degree

Job Type: Contract

Salary: From $35.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location