Quality Control Chemist-II

Aspire Pharmaceuticals•Somerset, NJ

About The Position

The Quality Control Chemist-II is responsible for performing complex and variety of analytical testing, ensuring the quality of dietary supplements and OTC products through testing, documentation, and compliance with regulatory standards. This position also involves reviewing and maintaining SOPs, Testing Procedures, calibrations, and other controlled documents to support quality assurance activities. Additionally, the Chemist-II will assist with troubleshooting and minor repairs of laboratory equipment and support stability testing and documentation. This mid-level position will require more independent work, the ability to mentor QC chemist-I and Lab Tech personnel, and involvement in process improvements and corrective actions.

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 3 - 5 years of experience in a quality control setting; or a Master’s Degree in a related field with 2 - 3 years of relevant experience; or an equivalent combination of education and experience. Experience with analytical techniques such as HPLC, GC, and spectrometry.
Computer and Mathematical Skills: Proficiency in Microsoft Office (Excel, Word, PowerPoint), and familiarity with Laboratory Information Management Systems (LIMS). Intermediate understanding of statistical analysis, data interpretation, and troubleshooting analytical methods.
Mathematical Skills: Math skills commensurate with a scientific background are required.
Communication Skills: Excellent written and verbal communication skills for reporting and presenting findings. Ability to work well with cross-functional teams and effectively communicate with supervisors and laboratory management.
Pharmaceuticals Industry Knowledge: Solid knowledge of cGMP, GLP, and regulatory requirements specific to the pharmaceutical industry.
Reasoning Ability: Strong analytical thinking, troubleshooting, and the ability to make decisions based on data and scientific principles.

Responsibilities

Comply with all regulatory and internal requirements and ensure all work is performed in compliance with cGMP, GLP, compendia standards, and internal procedures.
Follow all safety protocols, wear proper Personal Protective Equipment (PPE), and adhere to SOPs.
Conduct complex wet chemistry and analytical testing on raw materials, finished products, in-process samples, stability, and packaged products) according to Testing Procedures.
Perform Analytical Method Verification and Validation in accordance with USP, EP, and other regulatory standards.
Operate, maintain, and troubleshoot analytical instrumentation such as HPLC, GC, ICP-MS, FTIR, TOC, UV, Dissolution, and others, and resolve testing and equipment-related issues .
Strong problem-solving abilities, particularly when troubleshooting minor equipment or testing issues.
Maintain accurate records of all analyses, ensuring contemporaneous documentation and adherence to company standards.
Perform laboratory analysis right the first time and ensure all results are properly documented.
Prepare technical reports and maintain the records and summaries. Ability to analyze data and test results to identify deviations or nonconforming data.
Immediately notify the supervisor/manager of any nonconforming data or unexpected occurrences during testing.
Conduct laboratory investigations under the guidance of laboratory management.
Prepare and review Testing Procedures and Standard Operating Procedures (SOPs).
Review and interpret analytical data, identify trends, and make recommendations for process improvements.
Maintain General housekeeping practices, ensuring clean work areas during and after tasks, and keep workstations and equipment orderly.
Assist with laboratory chemical waste disposal and remain accountable for other assigned responsibilities.
Organize and prioritize work schedule to complete assigned tasks efficiently and on time.
Work effectively under the direction of supervisors and/or manager, and perform additional duties as required.
Keep accurate attendance records, file necessary reports (accidents, probation, etc.), and follow lean 6S principles for workplace organization.
Mentor QC chemist-I and Lab Tech personnel and assist with training new employees.