QA Inspector II - DPI

RXinsider LTD.; Hauppauge, Northern (NY, KY); Hybrid; USD 33,000 - 43,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

Health Savings Account

Flexible Spending Account

Paid time off

Paid holidays

Short-term disability

Long-term disability

Parental leave

Employee discounts

Job summary

InvaGen Pharmaceuticals, Inc. seeks a DPI QA Inspector II for the third shift in Hauppauge, NY. You will verify raw materials during dispensing, perform in-process checks, and collect samples for analysis following batch records.

The role requires a minimum science degree and 1–2 years of pharmaceutical experience; familiarity with cGMP and 21 CFR Part 820 is preferred. A comprehensive benefits package is offered along with competitive compensation.

Qualifications

• Minimum Science Graduate.
• 1–2 years pharmaceutical experience preferred.
• Experience in generic pharmaceutical manufacturing is a plus.

Responsibilities

• Verify raw materials during dispensing.
• Dispense printed packaging materials to packaging.
• Perform in-process checks per batch records.
• Collect in-process blend, finished product samples for analysis.
• Clean and maintain sampling rods/dies/boxes used for BU sampling.
• Perform IPQA tests on the manufacturing floor (LOD, Bulk Density, etc.).
• Clean equipment and provide line clearance.
• Post dispensed materials and samples into SAP.
• Investigate deviations and non-conformances.
• Complete training and follow cGMP and SOPs.
• Review batch records and logs.
• Isolate rejected materials and document in batch records.
• Review engineering records (temp, humidity, calibration).
• Daily quality rounds to ensure GMP compliance.
• Report to Manager any discrepancies.
• Other duties as assigned.

Skills

GMP Knowledge

Communication Skills

Microsoft Word/Excel

Attention to Detail

Math Skills

Education

Science Graduate

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: DPI QA Inspector II

Organization Name: InvaGen Pharmaceuticals, Inc.

Location: Unit 1 - 7 Oser Avenue, Hauppauge, NY 11788

Employment Type: Full Time

Shift: Third Shift: 11:00 PM - 7:30 AM (May vary based on business needs)

Salary Range (Base/salary): $24/hr - $31/hr

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, employee discounts, and other benefits.

Responsibilities/ Accountabilities

• Verification of raw materials during the dispensing process.
• Dispensing printed packaging materials to packaging.
• Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions.
• Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity (BU) sampling.
• To clean and maintain the samplings rods/dies/sample boxes used for BU sampling.
• Perform IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test.
• Ensure cleaning of manufacturing and packaging equipment, area and provide line clearance.
• To perform posting of dispensed materials and samples into SAP system (ERP system) and to perform other transactions in SAP.
• Involve in investigation of Deviation, OOS, OOT, or any other non-conformances.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's.
• Review of online batch records, area/equipment logbooks, calibration/PMP records etc.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Review of engineering records (temperature and humidity data, calibration reports and PMP records).
• To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
• Report, elevate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
• Other duties [additional support] that management may assign from time to time.

Education Qualifications/Experience

• Minimum Science Graduate
• A minimum of 1-2 years of pharmaceutical experience (DPI, MDI or Injectables) preferred.
• Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Skills/ Competencies

• Knowledge of Good Manufacturing Practices and 21 CFR Part 820.
• Ability to read, write and communicate effectively.
• Basic computer skills (Microsoft Word, Power and Excel).
• 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.
Remote work and relocation are note supported in this position.

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.

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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 reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

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.