Job Description

The Quality Control Laboratory Analyst supports Quality Control testing and Research & Development activities by performing routine laboratory testing of raw materials, in-process materials, finished products, and stability samples. This role ensures all testing is conducted in accordance with approved analytical methods, laboratory procedures, and applicable regulatory standards.

The analyst is responsible for executing laboratory work using established analytical techniques while maintaining compliance with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP). The role also includes accurate data analysis, documentation, and peer review of laboratory records to support product quality and regulatory compliance.

Laboratory Testing

• Perform routine laboratory testing for raw materials, in-process materials, finished product samples, and stability samples according to approved analytical methods and specifications.
• Prepare samples and reagents and operate laboratory equipment required for testing procedures.

Analytical Techniques & Compliance

• Conduct laboratory work using best-practice analytical techniques.
• Ensure all testing activities comply with laboratory Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
• Follow established standard operating procedures (SOPs), analytical methods, and laboratory safety protocols.

Data Analysis & Interpretation

• Analyze and interpret laboratory data using appropriate specifications and test methods.
• Investigate and report any out-of-specification (OOS) or atypical results according to established procedures.

Documentation & Data Integrity

• Maintain accurate laboratory records and documentation in compliance with regulatory and company requirements.
• Enter testing results into laboratory reporting systems and complete sample release forms as required.

Peer Review & Verification

• Perform peer review of laboratory notebooks, worksheets, and electronic records to verify accuracy and completeness of data supporting sample release.

Supplemental Functions

• Perform work under supervision using established procedures and pre-defined guidelines.
• Support laboratory and quality operations as assigned.
• Perform other related duties as required to support departmental objectives.

Requirements

Knowledge & Skills:

• Strong analytical skills, problem-solving ability, and attention to detail.
• An understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP standards.
• Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary under management guidance.
• Ability to perform testing for laboratory investigations for OOS and atypical QC test results under management guidance.
• Ability to effectively communicate within Chemistry Laboratory Staff and Management.
• Acknowledge and identify continuous improvement opportunities in all work activities.
• Ability to effectively use a multitude of resources to perform job functions accurately.

Education/Experience:

• BS or MS in Chemistry, Biochemistry, or related field required with 0-3 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate.
• Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required.
• Experience in more advanced techniques such as HPLC and GC is preferred.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.
• This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific.
• This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.

Job Tags

Full time

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