QC Chemist I

Job Description

job summary:

An individual contributor who performs testing of samples of various types using various techniques or equipment in the QC laboratory.

location: Central Islip, New York

job type: Permanent

work hours: 9 to 5

education: Bachelors

responsibilities:

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.

qualifications:

Required:

Bachelors degree in chemistry, pharmaceutical or related field is required

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 software's such as Empower3, Chromeleon preferred. Understanding or experience in other quality systems such as Trackwise, master control is a plus.

#LI-JW1

skills: High Pressure Liquid Chromatography (HPLC)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, 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 a reasonable accommodation to make your application or interview experience a great one, please contact .

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Full-time