Position Overview:

The QC Analyst - Chemistry will perform analytical chemistry testing and support Quality operations in a GMP laboratory environment. The ideal candidate will be very detail-oriented, have hands-on experience with analytical instrumentation, strong documentation skills, and the ability to work efficiently and effectively in a fast-paced setting.

Reports to: Director of Quality

Location: Alachua, FL 

Schedule: Monday - Friday, dayshift

Salary Range: $65,000 - $75,000

Key Responsibilities: 

• QC Analyst - Chemistry activities to include, supporting method selection and development, supporting method transfer, qualification and validation, monitoring routine use, and supporting investigation records.
• Support method transfer/qualification/validation activities 
• Assists in developing, troubleshooting, optimizing complex QC procedures according to regulatory requirements.
• Collaborate with department personnel to ensure analysts are trained on newly transferred/qualified/validated procedures.
• Analyze, document, and report experimental data in accordance to Strive requirements
• Collect/evaluate data trends to ensure qualified/validated methods remain in a state of control.

• Provide support to the Quality Control team as needed.
• Train analysts on analytical techniques
• Troubleshoot assay failures
• May require occasional early morning, late evening, and / or weekend work
• Perform analytical testing (GC, HPLC, FTIR) on raw materials and finished products.
• Review, organize and maintain laboratory documentation and records.
• Ensure compliance with GMP, safety, regulatory and corporate requirements.
• Conduct Out-of-Specification (OOS) and Out-of-Trend investigations.
• Work directly with vendors.
• Other activities as assigned.

Qualifications:

• BS in a Chemical Science field (Biochemistry, Analytical Chemistry, etc.), or related field and 2+ years of applicable industry experience.
• Experience with cGMPs applicable to the pharmaceutical industry.
• Strong verbal / written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
• Analytical problem-solving and troubleshooting skills.
• Adaptable and flexible in response to a dynamic operating environment.
• Solid understanding of laboratory practices and analytical activities.
• Ability to prioritize and balance multiple tasks.
• Proficiency with database applications.
• Ability to work efficiently in a team environment.
• Ability to interpret technical information, strong problem-solving skills.

Preferred Qualifications: 

• Experience with HPLC/UPLC assay and ID testing.
• Experience in a compounding pharmacy or outsourced testing facility.

Position and compensation levels are commensurate with level of education and experience.

Role/Site Specific Requirements:

This position may also include the following:

• This role is primarily a Sedentary role. This can include exerting up to 30 pounds of force to move objects.
• Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, general observations of facilities, etc.
• Participation in an occupational health program which can include; medical assessment, surveillance, vaccination, and testing
• Use of personal protective equipment which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.

Exposure to the following:

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.).
• Working in laboratories & production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.

The items described here are representative of those that must be met to successfully perform the essential functions of this job.