New

QA Specialist - Third Party Quality Assurance

Cipla USA

United States, New York, Central Islip

550 South Research Place (Show on map)

Jan 14, 2026

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: QA Specialist - Third Party Quality Assurance

Reports to: Lead - Quality CMO & Vendor Quality Management, Due Diligence

Location: Central Islip, New York

Pay Range: $72,800-$93,600

Employment Type:Full Time - Salaried/Exempt

Work Hours/Shift:8:30AM - 5:00PM

Job Purpose

Drive the strategic imperatives and operational performance of the quality assurance function at a external manufacturing site to ensure implementation of quality systems and successful delivery of business strategy while adhering to regulatory compliance at the site.

Key Accountabilities

Accountability Cluster	Major Activities / Tasks
Establish integration of Cipla Quality System with respect to Quality Operations at External/ Contract Manufacturing Site (CMO).	Develop and maintain a Quality Management System (QMS) at External Manufacturing site, ensuring compliance with 21 CFR Part 4 and part 820 regulations for combination products. Implement QMS improvement initiatives based on the review of CMO's existing system. Implementation of Cipla's corporate procedures at CMO as required to meet regulatory standards. Ensure equipment and software compliant with 21 CFR Part 11 at CMO. Manage QMS documentation review (Change control, Deviations. OOS and other investigation) received from CMO. Ensure the implementation of global Corrective and Preventive Actions (CAPAs) as decided to be implemented at the External Manufacturing Sites.
Plan and monitor the quality assurance activities at site by conducting site visits meetings / interactions meetings with team members and cross functionl teams and reviewing status of shop floor activities to ensure all technical issues are resolved in time for smooth shop floor operations as well as in Quality control laboratories.	Lead, support, and guide a quality team at CMO to ensure smooth operations across shop floor manufacturing, packaging, testing, validation, and qualification activities. Prepare, review, and approve protocols for transportation study.. Visit at site and monitor the batch manufacturin as per shceduled plan based on business need. Review and approve master batch records and executed batch records & tetsing timely for release. Ensure the timely issuance and review of logbooks across all departments. Review of Batch release documents received from CMO. Monitor daily observation rounds and ensure prompt closure of all discrepancies whenever visiting site. Preperations and periodic review of Quality Technical Agreements with CMO.
Resolve the queries / problem faced during investigations of the non-conformances by interacting with CMO investigation team and by trouble shooting the matters by visiting sites, in order to ensure that all the non-conformances are timely and correctly investigated and documented.	Assist in the effective investigation of deviations, incidences, laboratory non-conformances, and effectiveness of CAPAs. Review documentation for each investigation, including CAPAs, and implement best practices for addressing non-conformances. Monitor the timely closure of change controls, deviations, OOS, OOT, and CAPAs. Hold weekly meetings with the CFT and CMO to track investigation progress and provide input to ensure adherence to target closeout timelines. Offer technical to CMO through periodic meetings, on-demand interactions in coordination with cross functional team including but not limited to R&D, RA, Supply Chain etc.
Drive the effective usage of cGMP based policies, systems and procedures at the site by ensuring implementation of all required SOPs in order to ensure that individual activity is performed in compliance to GMP and regulatory requirements.	Review and evaluate regulatory guidelines and updates, ensuring the implementation of corresponding procedures at the site. Participate in Quality audits at Vendors/ suppliers or service providers supplying materials or services to InvaGen. Plan, Prepare Schedule for Due Deligience and periodic audits at contract manufacturing sites. Monitor the adequacy of compliance for periodic inspections, safety audits, unit operations, and regulatory audits, driving improvements in the system. Ensure the implementation of enhanced processes and corrective actions based on audit findings. Coordinate and support corporate function for conducting visits/ audits at different manufacturers as per the request. Identify, assess, and simplify complexities in shop floor processes while providing technical guidance to the team.
Ensure timely escalation of any non conformances, delay in the plan at site for smooth functioning of operations to meet production plan and achieve manufacturing OTIF within time and budget.	Timely communicate with cross functional team including but not limited to Supply chain Management/ Project Management for non-confirmances reported by CMO. Arranging or participating in meetings for project planning and executions.

Major Challenges

Delay in response from CMO, crossing SLAs, and overdue stability and non-routine activities due to high attrition at a TP site. Overcome by preparing for crisis management by generating ownership, multi-tasking skills among the employees and analysisng manpower requirement well in advance
High number of deviations due to errors committed by analyst/ Operators at CMOs while performing manual work. Overcome by conducting awareness sessions, weekly discussion on errors and effective monitoring
Impact on routine release and production plan due to fluctuation in material supply and major gap in forecast and actual execution and non-availability of approved PM standards. Overcome by timely escalation and followup to packaging development & purchase
Delay in approval of changes from Regulatory Affairs causing changes pending for implementation. Overcome by regular follow-up to get it approved

Key Interactions

Internal

External

Supply Chain Management For the routine commercials plans and delivery of products.
Regulatory Affairs for the approval of the change control and the export requirement (Weekly or Need basis)
CQA for the market complaint closing and recall activity, batch release issue, deviation investigation, CAPA approval and closing, market complaint investigation (Need basis)
IPD for manufacturing process & new launches (Need Basis)
Reporting Manager for technical and administrative issues etc. (Daily)
Head - Quality International for technical issues, decisions, status, compliance etc. (Need Basis)

Contract Manufacturing for audit and its compliance, technology transfers, QMS, investigations of non-compliances and its CAPA implementation verification (Regular basis)
Consultants for Technical issues (Need Basis)
Customers for approval of the major deviation, audit compliance and change control approval (Need Basis)

Dimensions

Operating Budget : USD XX per year (includes manpower cost : USD XX per year; OPEX : USD XX per year)
Direct Reports : 00
Team Size : (Organogram is attached)
Number of units managed : External Manufacturing Sites (minimum 15 for QMS monitoring)
Number of dosage forms handled : Multiple
Number of QA function managed : None
Number of microbiology Labs managed (if applicable) : NA
Number of audits : Around 25 batches per year
Number of documentation review including change controls. Investigations: 10 per month.
Number of Quality Technical Agreements: 15 per year

Key Decisions:

Decisions	Recommendations
Participate in troubleshooting and investigations at External Manufacturing sites. Approval of change request, Deviation and other QMS documentation. Resolution of any technical/analytical issues Quality Audits of CMO and Packaging site Approve the CAPA received related to audit findings.	Batch release and rejection to Lead Third Party Quality Operation Site Exits for CMO/ Vendor facilities to Lead Third Party Quality Operations Implenation of regulatory requiremnt and QMS with cordination of head quality and operation Head. Escalations of investigation or non-confirmances reported.

Skills & Knowledge

Educational qualifications:

B. Pharm/ M. Pharm or A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred.
Experience working in pharmaceutical QA is preferred.
Proficiently speak and write English as a first or second language.
Bi-lingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.
Proficiently communicate and understand (read and write) scientific / regulatory based 'work" in English.
Have excellent organization, learning and teaching skills required to work in teams.
Strong desire towards continuous improvement.
Know how to use Microsoft Office programs and other scientific based software

Relevant experience/ Additional responsibilities:

Minimum of ten (10) years of relevant experience in a Pharmaceutical FDA regulated industry in Quality Assurance and Compliance.
Minimum of five (5) years' experience of quality management in a pharmaceutical company.
Minimum of three (3) years relevant experience directing work in a group setting.
Solid project management skills and experience is required.
Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international.
regulations/guidelines.
Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as conducting Quality audits.
Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
Experience with sterile products and devices will be added advantage.
Should be willing and able to travel (maximum time) at external manufacturing sites as per the project plan and execution of batches.

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

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, 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.

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 ongeographic 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.