Quality Control Analytical Chemist I

About the role

Analyzes raw material compounds, bulk and finished goods to determine chemical and physical properties.

Completes routine review of QC test data and related documents for in-process samples, finished goods and stability samples.

Follows established procedures and documents all findings and results timely, concisely, clearly and accurately.

Prepares standards and specifications for processes, facilities, products, and tests.

Provides updates/escalations at daily and weekly site-specific and cross-site meetings.

Aids in root cause analyses and corrective/preventive action (CAPA) initiatives related to quality issues, including product Out-of-Specifications, deviations and consumer complaints.

Aids in improvements of the stability program, including initiating stability protocols, stability inventory schedules, stability pulls, ensuring timely testing of products, compiling stability reports, and trending data across the shelf-life of OTC products.

Collaborates with cross-functional teams to support continuous improvement initiatives.

Assists in the development, review, writing, and implementation of SOP's for quality functions to ensure compliance with all regulatory and GMP requirements.

Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations.

Experience with analytical testing methods (organoleptic, viscosity, pH, moisture, specific gravity, titration assays, FTIR) in cosmetic and OTC manufacturing environment to support QC testing, data reviews, & COA generation to support testing and release.

Assesses GMP systems currently in place to ensure compliance and provides solutions to improve quality systems.

Proficiency in MS Word, Excel, Power Point and other applications.

Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

Works with development of formulas, processes, and methods for solution of technical problems.

Strives toward continuous self-improvement in personal productivity.

Comfortable in a fast-paced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities.

May aid in monitoring and trending raw material, in-process, finished goods and stability data results.

Responsibilities

• Analyzes raw material compounds, bulk and finished goods to determine chemical and physical properties.
• Completes routine review of QC test data and related documents for in-process samples, finished goods and stability samples.
• Follows established procedures and documents all findings and results timely, concisely, clearly and accurately.
• Prepares standards and specifications for processes, facilities, products, and tests.
• Provides updates/escalations at daily and weekly site-specific and cross-site meetings.
• Aids in root cause analyses and corrective/preventive action (CAPA) initiatives related to quality issues, including product Out-of-Specifications, deviations and consumer complaints.
• Aids in improvements of the stability program, including initiating stability protocols, stability inventory schedules, stability pulls, ensuring timely testing of products, compiling stability reports, and trending data across the shelf-life of OTC products.
• Collaborates with cross-functional teams to support continuous improvement initiatives.
• Assists in the development, review, writing, and implementation of SOP's for quality functions to ensure compliance with all regulatory and GMP requirements.
• Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations.
• Experience with analytical testing methods (organoleptic, viscosity, pH, moisture, specific gravity, titration assays, FTIR) in cosmetic and OTC manufacturing environment to support QC testing, data reviews, & COA generation to support testing and release.
• Assesses GMP systems currently in place to ensure compliance and provides solutions to improve quality systems.
• Proficiency in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Works with development of formulas, processes, and methods for solution of technical problems.
• Strives toward continuous self-improvement in personal productivity.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities.
• May aid in monitoring and trending raw material, in-process, finished goods and stability data results.

Requirements

• Minimum 3 years of experience in a QC Laboratory or regulated manufacturing environment preferred (cosmetics or OTC drugs a plus).
• Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences).
• Working knowledge and understanding of GMP, FDA regulations and quality systems, and regulatory requirements (21 CRF Part 11/ 210/ 211).
• Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.
• Proficiency in Microsoft Office and familiarity with electronic quality systems is a plus.
• Maintains an exemplary attendance and punctuality performance record.
• Adheres to all Prime Personnel Policies as established by the company.

Qualifications

• Minimum 3 years of experience in a QC Laboratory or regulated manufacturing environment preferred (cosmetics or OTC drugs a plus).
• Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences).
• Working knowledge and understanding of GMP, FDA regulations and quality systems, and regulatory requirements (21 CRF Part 11/ 210/ 211).
• Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits.
• Strong attention to detail and organizational skills.
• Effective written and verbal communication skills.
• Proficiency in Microsoft Office and familiarity with electronic quality systems is a plus.
• Maintains an exemplary attendance and punctuality performance record.
• Adheres to all Prime Personnel Policies as established by the company.

Benefits

Competitive compensation package.

Health, dental, and vision benefits.

401K program.

The spirit of a startup with the security of an established, profitable industry leader.

The opportunity to make waves in a $250B industry.