Quality Control Analyst in Earlington, Pennsylvania

QC Analyst

We are seeking a detail-oriented QC Analyst to support a commercial production/CDMO laboratory in Sellersville, PA. The QC Analyst will perform analytical testing of raw materials, in-process samples, and finished products in a regulated manufacturing environment. The role requires hands-on experience with HPLC, GC, dissolution testing, and particle size analysis, along with the ability to review analytical data, interpret chromatograms, troubleshoot common chromatographic issues, and maintain accurate GMP/cGMP documentation.

Responsibilities:

• Perform analytical testing of raw materials, in-process samples, and finished products in support of commercial production and product release.
• Perform HPLC analysis, including solvent selection, sample preparation, extraction, concentration, dilution, column handling, instrument calibration, and operation using manual injection and autosampler techniques.
• Conduct GC analysis, dissolution testing, and particle size analysis.
• Analyze and interpret chromatograms and identify and troubleshoot common analytical issues, including poor peak shape, poor peak resolution, poor reproducibility, and baseline drift.
• Review analytical testing data for accuracy, completeness, and compliance with applicable procedures and quality requirements.
• Track analytical testing data and maintain or update applicable SOPs within LIMS.
• Maintain complete and accurate laboratory records and documentation in accordance with GMP/cGMP requirements.
• Follow established laboratory procedures, safety requirements, and quality systems applicable to a regulated manufacturing environment.

Required Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific field.
• Previous experience performing analytical testing in a commercial production, pharmaceutical, or CDMO environment.
• Previous experience reviewing analytical testing data in an industry setting rather than an academic laboratory.
• Hands-on HPLC experience, including solvent selection, sample preparation, column handling, calibration, and operation using both manual injection and autosampler systems.
• Experience with GC, dissolution testing, and particle size analysis.
• Demonstrated ability to interpret chromatograms and troubleshoot common analytical issues, including peak shape, resolution, reproducibility, and baseline drift.
• Experience tracking analytical data and updating or maintaining SOPs in LIMS.
• Ability to maintain accurate records and follow GMP/cGMP requirements in a regulated laboratory environment.
• Ability to provide two professional references from manager- or supervisor-level individuals who directly supervised the candidate as full-time employees.

Work Requirements:

• This position is fully onsite in Sellersville, Pennsylvania.
• Remote or hybrid work is not available for this position.
• Ability to work in a regulated commercial production/CDMO laboratory environment.
• Ability to perform laboratory activities and operate analytical instrumentation in accordance with established procedures and safety requirements.
• Employment and work authorization must comply with applicable federal, state, and local requirements.
• Reasonable accommodations may be available for qualified individuals with disabilities, consistent with applicable law.

Equal Opportunity

Employer:

We are an equal opportunity employer and consider qualified applicants without regard to legally protected characteristics under applicable federal, state, or local law. Employment decisions are based on job-related qualifications, business needs, and other lawful considerations.

Application:

Qualified candidates are encouraged to apply with an updated resume detailing relevant QC, analytical testing, HPLC, GC, LIMS, and regulated manufacturing experience. Candidates should be prepared to provide two professional references from manager- or supervisor-level individuals who directly supervised their work as full-time employees.