Cipla USA

QMS Specialist

CENTRAL ISLIP, NYPosted 30+ days ago

Job summary

  • Job post source

    This job is directly from Cipla USA

  • Job overview

    The QMS Specialist at Cipla USA is responsible for managing quality management system investigations and corrective actions to ensure compliance and product quality within the pharmaceutical manufacturing process.

  • Responsibilities and impact

    The role involves conducting investigations of deviations and complaints, performing root cause analysis, maintaining records, collaborating with various departments to implement CAPAs, and communicating findings to management.

  • Compensation and benefits

    The position offers a salary range of $70K - $90K along with comprehensive benefits including 401(k) with matching, health insurance, HSA, FSA, PTO, paid holidays, disability coverage, parental leave, employee discounts, and potential bonuses.

  • Experience and skills

    Candidates should have a bachelor's degree in Science, Pharmacy, or related field with 3-5 years of pharmaceutical manufacturing experience in Quality/QMS roles, knowledge of GMP, technical writing skills, proficiency in QMS software like TrackWise, and familiarity with regulatory guidelines.

  • Work environment and culture

    Cipla promotes a diverse and inclusive work environment valuing equal opportunity and supports applicants with accommodations during hiring processes.

  • Company information

    Cipla is a global pharmaceutical company with over 85 years of history, known for high-quality branded and generic medicines, with a strong presence in India, the U.S., and other markets through its subsidiary InvaGen Pharmaceuticals.

  • Job location and travel

    The job is based in Central Islip, NY, with shifts that may vary including first, second, or third shifts and schedules from Monday to Saturday depending on business needs.

  • Unique job features

    The role requires working with cross-functional teams and offers exposure to various QMS tools and regulatory standards, with a focus on pharmaceutical quality compliance.

Company overview

Cipla USA is a subsidiary of Cipla Limited, a global pharmaceutical company headquartered in India. Specializing in the development, manufacturing, and commercialization of generic and branded pharmaceuticals, Cipla USA focuses on respiratory, oncology, and anti-retroviral therapies. The company generates revenue through the sale of its diverse product portfolio, which includes prescription medications, over-the-counter products, and active pharmaceutical ingredients (APIs). Founded in 1935, Cipla has a rich history of innovation and commitment to affordable healthcare, playing a significant role in the global fight against HIV/AIDS by making antiretroviral drugs accessible.

How to land this job

  • Tailor your resume to emphasize your experience with pharmaceutical Quality Management Systems, particularly your expertise in conducting investigations of OOS, OOT, and deviations, and your proficiency with root cause analysis tools like 5-whys and fishbone diagrams.

  • Highlight your knowledge of cGMP, Good Documentation Practices, CAPA management, and familiarity with QMS software such as TrackWise, as these are key competencies for the QMS Specialist role at Cipla USA.

  • Apply through multiple channels including Cipla USA's official corporate careers page and LinkedIn to maximize your application visibility and reach.

  • Connect with current employees in Cipla’s Quality Assurance or InvaGen Pharmaceuticals divisions on LinkedIn; you can break the ice by commenting on recent company news, asking about their experience working on CAPA projects, or expressing genuine interest in Cipla’s commitment to quality and regulatory compliance.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'root cause analysis,' 'CAPA,' 'cGMP,' 'TrackWise,' and 'QMS,' ensuring your resume passes initial automated screenings.

  • Use Jennie Johnson’s Power Apply feature to automate tailoring your resume, applying through multiple channels, and identifying LinkedIn contacts, allowing you to focus your energy on preparing for interviews and networking effectively.

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