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QA Associate II

Posting Date:  Jul 5, 2024
Department:  Formulation
Business Unit:  Quality
Country:  United States
State:  New York
Location:  Central Islip
Req Id:  54732

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 Validation Associate II

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

Employment Type

(Hourly/ Full Time)

Full Time – Salaried/Exempt

Salary Range

(Base/ Hourly)

$65,000 - $72,500

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

General Shift: 8:30 AM – 5:00 PM

Responsibilities/ Accountabilities

Job Purpose

 

The QA Validation Associate role is responsible for providing Quality Assurance support for receiving/ releases GMP documentation of bulk drug substances and finished drug products. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements.

 

Duties and responsibilities

 

The general duties and responsibilities of the "QA associate II" include but are not limited to the following:

 

  • Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, and product specific documents
  • Independently executes batch record review for completeness, accuracy and cGMP compliance.
  • Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
  • Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
  • Compile and report performance metrics for Batch Review and Release
  • Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met.
  • Ability to quickly process complex information and make critical decisions with limited information required.
  • Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate.
  • Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities.
  • Prepare reports and keep upper-level management informed of progress, Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Collaborates within Manufacturing to resolve document discrepancies or errors as it relates to Good Documentation Practices.
  • Perform tasks in a manner consistent with all Cipla policies including safety (EHS), quality systems and cGMP requirements.
  • Understand risks and delays to batch release and communicate appropriately.
  • Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs.
  • Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch Disposition QA perspective as needed.
  • Works in a collaborative team setting within the Batch Disposition team, within the quality department and with quality counterparts including Manufacturing Operations, Technical Support, Supply Chain and Planning.
  • Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of products.
  • Other duties, as necessary

 

Education Qualifications

  • A minimum of a Bachelor’s degree in a relevant field of study from an accredited institution.
  • Knowledge of pharmaceuticals, manufacturing, utility, lab systems, and equipment, preferably in solid or semisolid dosage forms.
  • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical design/commission/validate processes and how they relate to regulatory requirements and cGMP regulations with U.S. FDA.
  • Knowledge of SAP System (Preferred)

Experience

  • Minimum 3-5 years of pharmaceutical experience.

Physical Requirements

  • Sitting at and/or working at a computer or other “screen” 75% or greater of an 8-hour period.

Other Information

  • No remote work available.

 

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.

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