QA Inspector II - 2nd Shift

Cipla; Fall River (MA); On-site; USD 35,817 - 45,460; Full time

Job summary

Cipla is seeking a full-time QA Inspector II for its Fall River, MA facility. The selected candidate will ensure product quality on the shop floor, conduct inspections, and maintain compliance with cGMP requirements. A Bachelor's degree in Pharmaceutical Science is required, along with at least two years of relevant experience. This role offers no remote work and requires working on shifts, including weekends as needed. Knowledge of cGMP and proficiency in Microsoft Office are essential.

Qualifications

• Minimum 2 years’ experience in cGMP pharmaceutical manufacturing.
• Must be proficient in English language.
• Ability to influence decision-making.

Responsibilities

• Monitor shop floor activities to ensure product quality.
• Conduct in-process testing and line clearances.
• Inspect in-process and finished product samples.

Skills

cGMP knowledge

Microsoft Office tools

SAP

Interpersonal relationship skills

Detail-oriented

Multitasking skills

Organizational skills

Leadership skills

Education

Bachelor’s degree in Pharmaceutical science or equivalent

Advanced vocational training in pharmaceutical manufacturing

Job description

Job Title: QA Inspector II - 2nd Shift

FLSA Classification: Full-Time, Non-Exempt Professional

Work Location: Fall River, MA

Work Hours: 2nd Shift: 3:00 PM – 11:30 PM (may vary based on business needs)

Reports To: Quality Control Manager

Salary Range: $26 - $33

Job Purpose

The purpose of the QA Inspector position is to monitor and ensure shop floor activities and ensure product quality is maintained throughout all phases of the manufacturing and packaging process in compliance with established specifications and standard operating procedures (SOPs).

Duties and Responsibilities

• Working knowledge of shop floor QA activities (Line clearance, in-process checks, sampling, calibration and verification of equipment).
• Perform line clearance, in-process testing as per batch record instructions.
• Review batch records.
• Preparation, issuance and review of logbooks.
• Conduct room and equipment checks prior to each stage of manufacturing following detailed written procedures.
• Execute sampling and inspections as required.
• Inspect in-process and finished product samples for the QC Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure proper isolation of rejected material during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records such as temperature and humidity data, calibration and PM records, pest control records and contractor related functions.
• Assess online batch records for completeness of signatures, entries, and actual reconciliation/yields before next processing step.
• Verify functionality of all equipment and associated controls during the batch run.
• Identify and report non-conformances and/or discrepancies to management.

Education and Experience

• Minimum 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.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Minimum of 2 years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation.
• Experience in MDI or combination products is preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the 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.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must be a self‑starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and leadership skills (written, verbal, and presentation).
• Must be detail-oriented with ability to multitask and prioritize tasks with strict deadlines.

Working Conditions

This role works in a cGMP manufacturing environment, wearing required personal protective equipment such as uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work may involve solvents, powders, or other materials common in a pharmaceutical manufacturing facility. The role may be assigned on a shift basis (Day, Evening, Night). Weekend or holiday work may be requested or required.

Physical Requirements

• Stand or walk unassisted for ≥75% of an 8‑hour period. Unassisted lifting up to 10 kg may be required.
• Able to always wear appropriate personal protective equipment when required.
• Sit at a desk and/or work at a computer or other "screen" ≥75% of an 8‑hour period.

Professional and Behavioral Competencies

• Willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Willing and able to work any assigned shift, including 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.

EEO Statement

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.