QA Operations Specialist

Job Title

Job Title
:
Quality Assurance Operation Specialist

FLSA Classification
:
Professional, Exempt

Work Location
:
Fall River, MA

Work Hours
:
General: 8:30 AM - 5:00 PM (may vary based on business needs)

Reports To
:
Quality Assurance Manager

Salary Range
: $76,000 - $103,000

The QA operation specialist (MDI) position is an individual contributor role and a member of the Inva Gen Pharmaceuticals Plant Quality Team. This role monitors and ensures validation and qualification of facility, utilities, equipment, processes, and ensures product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and SOPs, and provides guidance to QA associates.

• Review batch manufacturing/packaging records.
• Review engineering records such as temperature and humidity data, calibration, and PM records, pest control records, and contractor related functions.
• Review and approve manufacturing/engineering non-conformances.
• Review and approve manufacturing/engineering change control, deviation investigation, and CAPAs.
• Review and approve manufacturing/engineering validation and qualification documents.
• Provide daily/weekly updates to shop floor and management regarding quality highlights/concerns.
• Create lessons learned for training and communication with shop floor personnel.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report non-conformances and/or discrepancies to management if applicable.
• Verify functionality of all equipment and associated controls during batch runs.
• Act as quality lead for all shop floor questions/concerns.
• Provide backup for shop floor QA Associates.
• Complete other duties or participate in project work as assigned by management.

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field from an accredited college/university.
• Bachelor’s degree in pharmaceutical manufacturing, industrial management, or related field from an accredited college/university is preferred.
• Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation and environment.
• Experience in MDI or combination products is preferred.
• Current working knowledge of quality assurance (QA).
• Strong knowledge and experience with analytical laboratory activities in areas such as API, drug products, analytical development, QC, GLP, GMP, GDP, etc.

• Understanding of machines used in pharmaceutical manufacturing.
• Ability to influence decision making and facilitate work towards achieving business plan and goals.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Capability to conduct troubleshooting, investigations, and root cause analysis.
• Capability to handle and participate in compliance and regulatory audits at local and federal levels.
• Proficient in Microsoft Office and other software applications.
• Experience using SAP business system and applications is a plus.
• Experience in inhalation products (MDI) or combination products is a plus.
• Ability to work in a fast‑paced, dynamic manufacturing environment.
• Strong communication skills across all levels; solid command of English (verbal, written, interpersonal).
• Excellent documentation and technical writing skills; able to apply relevant scientific principles and practices.
• Ability to work under minimal supervision and independently; exercise professional judgment on matters of significance.

• Proficient user of personal computer hardware and software applications such as Microsoft Office, SAP, and other business applications.
• Influence decision-making and facilitate work towards achieving business plan and goals.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Proficiency in English language, including usage, spelling, grammar, and punctuation.
• Current Good Manufacturing Practices (cGMP) knowledge.
• Self‑starter with initiative to seek additional training or direction as…