QC Chemist

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

QC Chemist I

Organization Name

Inva Gen Pharmaceuticals, Inc.

Location

Central Islip, NY

Employment Type

Full Time - Salary/Exempt

Salary Range

$66,300 - $75,400

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

8:30 AM - 5:00 PM (General Shift)

Responsibilities/ Accountabilities

• Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
• Strong analytical skills, attention to detail, knowledge of analytical techniques (HPLC, GC, UV-Vis etc.) and familiarity with quality control procedures.
• Responsible for performing routine analytical testing of raw material, in-process samples, finished products to ensure they meet quality standards and regulatory requirements.
• Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate cross-functionally and communicate effectively.
• Responsible for QA review and approval of the following types of documents:
• SOP's
• GMP documents
• Change control documents
• Review of system records
• Perform activities related to periodic audit trail review of all quality softwares, ensure compliance within the systems etc.
• Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices (cGMP) and GLP systems both manual and automated.
• Follow all safety procedures and guidelines to ensure a safe laboratory environment.
• Prioritize risks and work with IT, QA, laboratory personnel to mitigate data integrity gaps.
• Partnering with other members of the Quality Assurance team and/or end users of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures.
• Evaluate proposed and existing software systems that support laboratory and software applications for data integrity gaps. Works with IT and QA to resolve those gaps.
• Develop standard operating procedures for the administration of analytical and QC equipment.
• Ensuring the GMP status and the functionality of the laboratory equipment in accordance with the guidelines 21 CRF Part 11 on data integrity.
• Excellent written and verbal communication skills.
• Perform additional duties as requested.

Education Qualifications/Experience

• Entry level position.
• Master's degree in chemistry, pharmaceutical or related field is required.
• May require 1+ years' experience in a pharmaceutical manufacturing lab.

• Experience and understanding of the Laboratory Information Management Systems (LIMS) is a plus.
• Understanding of systems such as polarimeter, IR spectroscopy, Karl Fischer etc. is expected.
• Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required.
• Experience in Chromatographic softwares such as Empower3, Chromeleon preferred. Understanding or experience in other quality systems such as Trackwise, master control is a plus.

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.

Inva Gen Pharmaceuticals, Inc.

Inva Gen 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…