Manufacturing Specialist

Compliance Specialist II (Manufacturing/Quality) 1st Shift

1 Year

Northborough, MA

Job Responsibilities

This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Label and Packaging operations, finished goods and raw material disposition.

Responsibilities include:

• Performing finished product disposition in accordance with company’s SOP's, in-house product specifications and market regulations
• Reviewing and approving validation protocols and change controls
• Authoring, revising and reviewing SOP's through Veeva System
• Utilizing Veeva to complete investigation of deviations, CAPAs and Change Controls
• Supporting compliance walkthroughs, Participate in internal audits
• Participate in QA audit readiness program as well as assist and participate in external audits and regulatory inspections
• Interpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trends
• Completing analysis, identifying issues and providing recommendations for compliance improvements
• Completing Quality Events in Veeva
• Development and training of new staff as needed
• Participate in specialized projects both within Quality and cross-functionally
• Perform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lots
• Support additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming Materials
• Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities
• Maintaining material master data in ERP system
• Following accurate oral & written procedures in performing QA tasks
• Staying up-to-date on training of all procedures
• Routinely and safely handle high value product vials in various stages of packaging completion
• Adhering to company’s safety procedures and guidelines
• Participate in Lean initiatives to improve Quality processes
• Participate in the QA consistency meetings to support continuous improvement efforts
• Support the QA on the floor initiatives which includes; attending daily capacity management and QDCI meetings and assisting customers with resolution of issues in real time
• Effectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashion
• Ensure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)
• Comply with the requirements of company’s health and safety program.

Education & Qualifications

• Education: Bachelor’s in Chemistry or Biology highly preferred but open to a BA in other sciences

• Must-Have Experience with: SAP, GMP, industry experience in quality control/manufacturing

• Preferred Experience: VEEVA

• Work Experience: minimum 4-5 (academia or industry)