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    Qa Inspector Ii - Dpi

    Cipla
    3+ years
    Not Disclosed
    Hauppauge
    10 Feb. 7, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    QA Inspector II - DPI

    Posting Date: February 1, 2025
    Country: United States
    State: New York
    Location: Hauppauge
    Req Id: 91960

    Job Title

    QA Inspector II

    Organization Name

    InvaGen Pharmaceuticals, Inc.

    Location

    7 Oser Ave, Hauppauge, NY 11788

    Employment Type

    Full Time – Hourly/Non-Exempt

    Salary Range

    $20 - $29 per hour

    Benefits

    • 401(k) savings plan with 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

    Shift

    2nd Shift – 3:00 PM – 11:00 PM

    Responsibilities/Accountabilities

    • Monitor and ensure product quality throughout the manufacturing or packaging process.
    • Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability) per batch record instructions.
    • Conduct room and equipment checks before each manufacturing stage as per written procedures.
    • Perform AQL, blend sampling, in-process sampling, and inspections as required.
    • Prepare in-process and finished product samples for the QC lab, ensuring proper documentation and delivery.
    • Maintain standard weights and perform daily balance verifications, which includes carrying up to 100 kg (25 kg x 4 weights) for multiple balances.
    • Ensure proper isolation of rejected material and accountability within batch records.
    • Monitor facility and product environmental operating conditions.
    • Review engineering records, including temperature/humidity data, calibration, pest control, and contractor activities.
    • Review online batch records for completeness, reconciliation, and compliance before the next processing step.
    • Verify equipment functionality and associated controls during batch runs.
    • Perform testing and prepare reports for customer complaints.
    • Identify and report non-conformances or discrepancies to management.
    • Perform other duties as assigned by management.

    Education Qualifications

    • Minimum of a High School Diploma or equivalent (GED) required.
    • Proficiency in English (spoken and written) required.
    • Ability to read and write scientific documentation in English.
    • Strong organizational, learning, and teaching skills to work effectively in teams.
    • Working knowledge of Microsoft Office and other scientific-based software.

    Experience

    • Minimum of three (3) years of pharmaceutical QA experience required.

    Skills/Competencies

    • Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) preferred.
    • Strong communication skills (reading, writing, and speaking).
    • Self-motivated and able to work in a fast-paced manufacturing environment.
    • Excellent organizational skills with a keen eye for detail.
    • Strong mathematical skills and knowledge.

    Physical Requirements

    • Ability to stand or walk unassisted for 75% or more of an 8-hour shift.
    • Ability to lift up to 35 lbs. unassisted.
    • Required to wear personal protective equipment (PPE) as necessary.

    Other Information

    • This role operates in a cGMP laboratory or manufacturing environment, requiring PPE such as uniforms, lab coats, safety glasses, respiratory protection, and hearing protection.
    • Work may involve exposure to solvents, powders, and other pharmaceutical materials.
    • The role may require day, evening, or night shifts, as well as weekend or holiday work when necessary.
    • No remote work available. No relocation assistance provided.

    About Cipla

    Cipla is a global pharmaceutical leader dedicated to high-quality, branded, and generic medicines. For over 85 years, Cipla has strengthened its leadership in the pharmaceutical industry, expanding globally across key markets in India, South Africa, the U.S., and emerging economies.

    Guided by the motto ‘Caring for Life,’ Cipla focuses on delivering affordable, world-class medicines with uncompromising quality standards. Cipla continues to expand its portfolio, particularly in the U.S. market, with both generic and branded divisions.

    About InvaGen Pharmaceuticals, Inc.

    InvaGen Pharmaceuticals, a Cipla subsidiary, specializes in the development, manufacturing, marketing, and distribution of generic prescription medicines. With expertise in cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressant therapies, InvaGen has been a trusted provider since 2003. In October 2020, InvaGen expanded operations to Fall River, Massachusetts, supporting Cipla’s respiratory business launch in the U.S.

    Equal Opportunity Employer

    Cipla is committed to a diverse and inclusive workforce. We prohibit discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, protected veteran status, or any legally protected group.

    We welcome applicants of all abilities and strive for an accessible hiring process. If you require reasonable accommodation, please contact the recruiter.

    Salary and Pay Disclaimer

    The salary range stated is an anticipated base salary range for this role. Exact compensation will depend on experience, skills, education, and location. Additional benefits and performance-based bonuses may be available.

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