QC Chemist I

Cipla•Central Islip, NY

12h•Onsite

About The Position

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.

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.
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

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.
Perform routine analytical testing of raw material, in-process samples, finished products to ensure they meet quality standards and regulatory requirements.
QA review and approval of documents such as SOP’s GMP documents Change control documents
Perform activities related to periodic audit trail review of all quality softwares, ensure compliance within the systems etc.
Maintain regulatory compliance in accordance with cGMP
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.
Partner with Quality Assurance team members and/or end users 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.
Ensure 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.