QC Chemist I

Cipla • Central Islip, NY

7d • Onsite

About The Position

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 InvaGen 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)

Requirements

• Strong analytical skills, attention to detail, knowledge of analytical techniques (HPLC, GC, UV-Vis etc.) and familiarity with quality control procedures.
• Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate cross-functionally and communicate effectively.
• Excellent written and verbal communication skills.
• Entry level position.
• Master’s degree in chemistry, pharmaceutical or related field is required.
• May require 1+ years’ experience in a pharmaceutical manufacturing lab.
• Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required.

Nice To Haves

• 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.
• Experience in Chromatographic softwares such as Empower3, Chromeleon preferred.
• Understanding or experience in other quality systems such as Trackwise, master control is a plus.

Responsibilities

• 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.
• Responsible for performing routine analytical testing of raw material, in-process samples, finished products to ensure they meet quality standards and regulatory requirements.
• 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.
• Perform additional duties as requested.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level