QA Inspector I

About Cipla

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.

Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary 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. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States.

Job Title

QA Inspector I/II/III

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

7 Oser Ave, Hauppauge, NY 11788

Employment Type

(Hourly/ Full Time)

Full Time - Hourly/Non-Exempt

Salary Range

(Base/ Hourly)

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

Work Hours/ Shift/ Remote

Shifts:

1st Shift - 7:00 AM - 3:30 PM

2nd Shift - 3:00 PM - 11:00 PM

3rd Shift - 11:00 PM - 7:00 AM

Responsibilities/ Accountabilities

The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications.

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Perform room and equipment checks (where applicable) prior to each stage of manufacturing process as guided through written procedures.
• Perform AQL, Blend sampling, In-process Sampling, and inspections as required.
• Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.
• Maintenance of standard weights and perform daily verification of balances which includes physically carrying ability of 100 kg (25 Kg x 4 No's) weights for multiple 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 (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verification of 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/discrepancies to management if applicable.
• Other duties that management may assign from time to time.
  

Education Qualifications

• Must have a minimum of a High School Diploma or equivalent education credential (ex. GED) required.
• Proficiently speak English as a first or second language
• Proficiently communicate and understand (read and write) scientific work in English.
• Have excellent organization, learning and teaching skills required to work in teams.
• Working knowledge of Microsoft Office programs and other scientific based software
  

Experience

• Must have a minimum of three (3) years of pharmaceutical QA experience.
  

Skills/ Competencies

• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organization skills with strong attention to details skills.
• Strong fundamental mathematical skills and knowledge
  

Physical Requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period.
• Unassisted lifting up-to 35 lbs., may be required.
• Able to wear appropriate personal protective equipment at all times, when required.
  

Other Information

This role works in a cGMP laboratory or 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 laboratory or 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.

No remote work available & no relocation

Equal Opportunity Employer

Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard towithout regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected bylocal, state, or federal laws, rules, or regulations.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact careers.northamerica@cipla.com.

Pre-employment Process

Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing.

Disclaimer on Pay Ranges

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.