Quality Control Analytical Chemist I

Prime Matter Labs•Torrance, CA

4d•Onsite

About The Position

The QC Analytical Chemist I will analyze raw material compounds, bulk, and finished goods to determine chemical and physical properties. This role involves the routine review of QC test data and related documents for in-process samples, finished goods, and stability samples. The chemist will follow established procedures, document findings and results accurately, and prepare standards and specifications. This position will provide updates and escalations in daily and weekly meetings, aid in root cause analyses and CAPA initiatives for quality issues, and assist in improving the stability program. Collaboration with cross-functional teams for continuous improvement is expected, as is assisting in the development, review, writing, and implementation of SOPs for quality functions to ensure regulatory and GMP compliance. Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations is required. The role also requires experience with analytical testing methods in a cosmetic and OTC manufacturing environment, assessment of GMP systems, and proficiency in MS Office. The chemist will work on developing formulas, processes, and methods, strive for continuous self-improvement, and be comfortable in a fast-paced environment with minimal direction. The role may also involve monitoring and trending data results.

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.
Proficiency in MS Word, Excel, Power Point and other applications
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced environment with minimal direction and able to adjust workload and flexibility based upon changing priorities
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.
Maintains an exemplary attendance and punctuality performance record.
Adheres to all Prime Personnel Policies as established by the company.

Nice To Haves

Demonstrated self-management skills, including establishing direction and goals, and building good work ethics for the team
Experience with microbiological testing methods.
Familiarity with electronic quality systems is a plus.

Responsibilities

Analyzes raw material compounds, bulk and finished goods to determine chemical and physical properties.
Complete 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.
Provide 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.
Collaborate 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.
Assessment of GMP systems currently in place to ensure compliance and provides solutions to improve quality systems.
Works with development of formulas, processes, and methods for solution of technical problems.
Strives toward continuous self-improvement in personal productivity.
May aid in monitoring and trending raw material, in-process, finished goods and stability data results.