USA-Quality Control Analyst II (Manufacturing/Quality) 1st Shift

Job Title: Quality Control (QC) Analytical Chemist
Duration: 12 Months (Possibility of extension)
Location : Swiftwater PA

Overview:
The Quality Control Analytical Chemist supports routine testing within the QC Analytical Chemistry laboratory, focusing primarily on chemistry assays related to Incoming Quality and Raw Materials. This role requires a solid understanding of assay theory, laboratory processes, and equipment operation, along with the ability to identify and troubleshoot issues or trends. The successful candidate will ensure timely completion of testing activities while strictly adhering to 's policies, procedures, and current Good Manufacturing Practices (cGMP).
Key Responsibilities:

• Conduct QC testing in compliance with policies, safety procedures, SOPs/SWIs, Pharmacopeia standards, federal regulations, and cGMP guidelines.
• Execute scheduled laboratory activities to support Production, Method Development, Validation, Independent Demand, and Stability programs.
• Maintain a safe and compliant laboratory environment.
• Perform routine cleaning and maintenance of laboratory areas and equipment.
• Prepare, set up, and operate QC equipment, including pre- and post-run maintenance tasks.
• Accurately complete all required documentation and paperwork associated with testing activities.
• Investigate and resolve sample discrepancies and data anomalies.
• Conduct peer reviews and proofing of assay results.
• Develop familiarity with applicable compendia and regulatory guidelines.
• Participate actively in team, departmental, and safety meetings.

Specific Tasks May Include:

• Testing of raw materials using pharmacopeia and wet chemistry assays.
• Water quality testing including Total Organic Carbon (TOC) and Conductivity analysis.
• pH testing for media preparation.
• Buffer assays using titration and photometric techniques.
• Setup, operation, and maintenance of analytical instrumentation.
• Sample preparation and proper disposal procedures.
• Coordination and communication with contract laboratories for outsourced testing.

Additional Requirements:

• Chemical handling is required; appropriate Personal Protective Equipment (PPE) will be provided. Vaccinations and vision exams may be mandated based on job functions.

Qualifications:

• Bachelor's degree in Chemistry or a related field.
• 2 to 4 years of experience in a cGMP-regulated pharmaceutical or related industry environment.
• Strong attention to detail with excellent written communication skills.
• Ability to thrive in a dynamic team environment and maintain flexibility to accommodate weekend or holiday shifts as needed.
  
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