QA Operations Specialist

Job Title

QA Operations Specialist (MDI) – Fall River, MA – Full‑Time, Exempt/Salary Professional

The purpose of the QA operation specialist (MDI) position is to monitor and ensure validation and qualification of facility, utilities, equipment, processes and to maintain product quality throughout all manufacturing phases in compliance with established specifications and SOPs, while providing guidance to QA associates.

• Review and approve qualification and validation protocols and reports, including URS, FDS, FAT, SAT, DQ, IQ, OQ and PQ, with all supporting documentation.
• Review and approve User Requirement Specifications (URS) for equipment, systems and utilities.
• Prepare, review and approve Process Validation protocols and reports in accordance with lifecycle validation principles.
• Prepare, review, and approve Cleaning Validation protocols and reports for product‑contact equipment and manufacturing areas.
• Ensure all qualification and validation activities are planned and executed in alignment with applicable regulatory requirements (FDA, EU Annex 15, ICH Q8/Q9/Q10) and internal SOPs.
• Collaborate with cross‑functional teams (Engineering, Manufacturing, QC, Regulatory Affairs, IT, etc.) to support new projects, equipment implementation and changes requiring validation.
• Provide QA oversight during equipment commissioning, facility upgrades and utility system qualification activities.
• Ensure risk assessments (e.g., FMECA) are performed and documented for validation and qualification activities.
• Maintain and manage the Validation Master Plan (VMP) and ensure periodic review and timely execution of requalification/revalidation activities.
• Participate in investigations of deviations, out‑of‑specification results and non‑conformances related to validation, contributing to development and closure of effective CAPAs.
• Ensure validation and qualification documentation supports data integrity and complies with 21 CFR Part 11 for computerized systems.
• Maintain all validation lifecycle documents in accordance with company policies and cGMP expectations, ensuring traceability and audit readiness.
• Support internal and external audits, including FDA and other regulatory authority inspections, by providing relevant validation records, responses and justifications.

• Bachelor's degree in Pharmaceutical science or Equivalent.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field from an accredited college/university is preferred.
• Minimum of 3 to 5 years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation.
• Experience in MDI or combination products is preferred.
• Proficiency with personal computer hardware and software applications such as Microsoft Office, SAP, TW and other business applications.
• Ability to influence decision‐making and facilitate completion of work toward the business plan and goals.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Proficiency in the English language, including usage, spelling, grammar and punctuation.
• Current knowledge of Good Manufacturing Practices (cGMP).
• Self‑starter with initiative to seek additional training or direction as needed.
• Strong organization and leadership skills (written, verbal and presentation).
• Detail‑oriented with ability to multitask and prioritize tasks under strict deadlines.

This role works in a cGMP manufacturing environment. Personal protective equipment (PPE) is required; this may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders or other materials commonly found in a pharmaceutical manufacturing facility is required. The role may be assigned on a work‑shift basis (Day, Evening, Night) and weekend or holiday work may be requested or required.

• Work standing or walking unassisted for 75% or greater of an 8‑hour period. Unassisted lifting up to 10 kg may be required.
• Always wear appropriate personal protective equipment when required.
• Sitting at a desk and/or working at a computer or other screen 75% or greater of an 8‑hour period.

• Willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
• Willing to work some weekends based on business needs as required by management.
• No remote work available.

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.