QA Inspector II - 2nd Shift

RXinsider LTD.; Fall River (MA); On-site; USD 36,000 - 45,000; Full time

Job summary

Cipla is seeking a QA Inspector II for the Fall River, MA site. This role supports the InvaGen Pharmaceuticals Plant Quality Team on the 2nd shift, ensuring product quality and compliance with SOPs. Strong attention to detail and prior cGMP QA experience are required.

The position involves line clearance, in-process checks, sampling and batch-record review in a GMP environment, with opportunities for growth within a global pharma group.

Qualifications

• High school diploma required; pharma training preferred.
• Experience in cGMP pharma manufacturing is preferred.
• Proficiency with SAP and MS Office is required.

Responsibilities

• Monitor shop floor QA activities and line clearance per SOPs.
• Perform in-process testing and sampling per batch records.
• Review batch records and logbooks for accuracy.
• Inspect equipment, maintain calibration records, and verify yields.
• Identify non-conformances and report to management.

Skills

Line clearance

In-process testing

Batch records review

Documentation

SAP

Microsoft Office

English proficiency

Team collaboration

Detail orientation

Problem solving

Education

High school diploma

Advanced vocational training or college education in pharma/manufacturing

Experience in cGMP pharmaceutical manufacturing

Tools

SAP

Microsoft Office

Job description

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title: QA Inspector II - 2nd Shift
FLSA Classification: Full-Time, Non - Exempt Professional
Work Location: Fall River, MA
Work Hours: second Shift: 3:00 PM – 11:30PM (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:

The QA Inspector (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:

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

Education and Experience:

• Minimum high school diploma
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Minimum of 3years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
• 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 the ability to work in a team environment.
• Proficiency in the English language to include 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 the ability to multitask and prioritize tasks with strict deadlines.

Working conditions

This role works in a cGMP manufacturing environment, where personal protective equipment is required, which 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, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.

Physical requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required.
• Able to 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.

Professional and Behavioral Competencies:

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

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

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.