QC Chemist III

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Job Title : Quality Control (QC) Chemist III

FLSA Classification : Full-Time Exempt Professional

Work Location : Central Islip NY (Unit 3)

Work Hours: General Shift: 8:30AM 5:00PM (may vary based on business needs)

Reports To : Quality Control Manager

Salary: $96000 - $103000

Scope :

The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role responsibilities and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties tasks skills and qualifications. The intent is to give a general scope of the knowledge skills and abilities needed to satisfactorily perform the essential functions of the position and provide basic performance expectations. The scope of the job may be modified with respect to the department group and on an individual assigned basis to a sometimes-specific testing group. Consideration of education relevant training and experience or a combination of all three may also result in further modification of the role.

Duties and Responsibilities

• Hands-on experience in Raw materials Finished Product and Stability sample testing within a pharmaceutical Quality Control laboratory.
• Strong knowledge of chromatographic techniques including assay testing related substances (impurity profiling) degradation product analysis and purity determination using HPLC UPLC GC and IC systems.
• Proficient in operating and troubleshooting analytical instruments such as HPLC GC IC Dissolution Testers Karl Fischer (KF) FTIR and XRPD.
• Sound understanding of Good Laboratory Practices (GLP) Good Documentation Practices (GDP) data integrity requirements and laboratory compliance expectations.
• Experience with chromatography data systems and laboratory software including Empower LabSolutions Tiamo and other computerized laboratory systems.
• Working knowledge of laboratory management systems such as LIMS and quality management software such as TrackWise.
• Familiarity with testing and analytical requirements for Oral Solid Dosage (OSD) pharmaceutical products.
• Ability to perform method execution data review troubleshooting and investigation activities related to laboratory testing.
• Experience in supporting and interacting with regulatory and customer audits including USFDA
• Strong technical understanding of pharmaceutical analytical methodologies laboratory investigations and compliance-driven laboratory operations.
• Effective communication documentation and problem-solving skills with the ability to work independently and within cross-functional teams.
• Technical clarity : Added assay impurity degradation product and purity testing requirements.

Education and Experience

• Bachelors degree (BS or BA)Chemistry Pharmaceutical Sciences Pharmacy or a related scientific field.
• Masters degree preferred
• Chemist III - minumum of 5years experience.
• Experience in pharmaceutical QC testing with emphasis on chromatographic assays impurity profiling degradation studies and stability evaluation.
• Knowledge of data integrity principles and computerized analytical systems compliance.

Working conditions

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.

The role may be assigned on a work-shift basis where required (Day Evening Night). Weekend or Holiday work may be requested or required.

Physical requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to10 kg may be required.
• Able to wear appropriate personal protective equipment at all times when required.
• Sitting at a desk and/or working at a computer or other screen 75% or greater of an 8-hour period.

Professional and Behavioral Competencies

• Must be willing to work in a pharmaceutical packaging setting.
• Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available
• No employment sponsorship or work visas.

GLOBAL COMPANY

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 Indias 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.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision none shall be denied Ciplas focus has always been on making affordable world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS INC.)

About InvaGen Pharmaceuticals a Cipla subsidiary InvaGen Pharmaceuticals Inc. is 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. As of February 18 2016 InvaGen Pharmaceuticals Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement

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 or protected veteran status.

Required Experience:

IC