QA Inspector I - 2nd Shift

Cipla USA Inc.; Fall River (MA); In loco; USD 32.000 - 41.000; Tempo pieno

Descrizione del lavoro

Cipla USA Inc. in Fall River, MA seeks a QA Inspector I for the 2nd shift to monitor product quality across manufacturing stages in a GMP environment. The role involves in-process testing, equipment and room checks, and strict documentation.

Requirements include a high school diploma, with 2+ years in QA within GMP pharma; preferred MDI experience. Proficiency in MS Office and SAP is expected, along with strong attention to detail and teamwork.

Competenze

• Minimum high school diploma.
• Advanced vocational training or education in pharmaceutical manufacturing preferred.
• Minimum of two (2) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation.
• Experience in MDI preferred.

Mansioni

• Perform in-process testing (weight, thickness, hardness, disintegration, friability, etc.).
• Conduct room and equipment checks prior to each manufacturing stage.
• Execute AQL sampling and inspections as required.
• Inspect in-process and finished product samples for QC Lab and document results.
• Maintain records of standard weights and daily balance verification.
• Ensure proper isolation of rejected material and accountability in batch records.
• Monitor facility and product environmental conditions.
• Review engineering records (temperature, humidity, calibration, PM, pest control).
• Assess batch records for completeness before next step.
• Verify equipment functionality during batch run.
• Prepare reports for customer complaints.
• Identify and report non-conformances to management.

Conoscenze

MS Office

SAP

Attention to detail

Communication skills

Formazione

High school diploma

Technical training in pharma manufacturing preferred

Strumenti

Microsoft Office

SAP

Descrizione del lavoro

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 I - 2nd Shift

FLSA Classification: Full-Time, Non-Exempt/Hourly Professional

Work Location: Fall River, MA

Work Hours: Second Shift: 3:00PM – 11:30PM (May vary based on business needs)

Reports To: Quality Assurance Manager

Salary Range: $23 - $30

PURPOSE

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

Job Description

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the results to the 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.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

Education And Experience Qualifications

• 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.
• Minimum of two (2) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI preferred.

Knowledge, Skills, And Abilities

• 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 have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

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.