Job description

The Quality Control Analyst III performs all testing and solution preparations, performs complex instrumental calibrations and maintenance, communicates between departments when reporting results, and executes all protocols as assigned by management. The analyst is also responsible for writing protocols & reports as well sampling raw material, finished goods, stability samples and additional samples as assigned. The Quality Control Analyst III is responsible for training new employees when necessary. This position is required to be fluent in all testing and laboratory requirements. The Quality Control Analyst III is also responsible for overseeing daily laboratory functions, in the absence of the Quality Manager, and ensuring that all finished good testing is executed by the required dates. Must be able to perform all duties of the QC Analyst Levels up to II.

Essential Duties and Responsibilities:

• Prepares all solutions needed for testing
• Performs testing on stabilities
• Samples raw material, finished goods, stability samples and additional samples as assigned.
• Performs instrument & equipment calibrations/performance checks
• Performs testing on raw material, in-process, & finished good samples
• Documents all data in corresponding laboratory notebook
• Disposes of all chemicals safely
• Performs required testing pertaining to customer complaints, discrepancies, & laboratory investigations
• Reports necessary results to production supervisors, in a timely manner
• Reviews laboratory SOPs
• Performs specific testing methods; trace metal analysis on AAS and enzyme testing
• Performs impurity, supplier approval, and research testing
• Troubleshoots and maintains complex instruments
• Executes basic & complex protocols, as assigned by management
• Writes protocols and reports
• Ensures that the required samples are sent for outside testing
• Required to update the QC Laboratory Status
• Oversees daily laboratory functions in the absence of the Quality Manager; if there are multiple analysts in this position, the manager will designate duties accordingly
• Ensures the execution of finished good testing is performed on time; in the case that testing is not complete, possibly leading to a delay in the shipment of a product, the Quality Manager is immediately notified
• Available for employee review inquiries
• Trains new employees
• Trains Production employees
• Reviews laboratory notebooks
• Verifies laboratory testing and calibrations checks
• Places approved orders with Purchasing Specialist in the absence of the Quality Manager
• Other duties may be assigned

Qualifications:

• Bachelor’s degree or higher in Science Field, Chemistry Degree or other related field and/or commensurate experience required.
• 5 years’ experience in pharmaceutical or related industry in a laboratory setting, with knowledge of cGMP and related compliance regulations and guidance, is required.
• Ability to interpret data, perform complicated analytical calculations and statistical analysis
• Must be able to communicate technical, scientific, and regulatory information, both written and verbally
• Must be able to work in a cross-functional environment to interact with multiple departments
• Prior experience, with a minimum of 2 years of direct hands-on laboratory experience in a GMP laboratory is required.
• Experience with HPLC, Titrations and IR
• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word

Physical Requirements:

• Lift up to 20 lbs.
• Bend, stoop, carry, and reach
• Climb and/or stand on an elevated bench or step stool
• Sit and/or stand for extended periods
• Ability to see and distinguish color
• Work with chemicals and/or hazardous materials

Work Hours:

• Non-Exempt Position
• Minimum of 8 Hour Shift, 5 Days a Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities

Job Type: Full-time

Pay: From $24.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Rensselaer, NY 12144: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Laboratory experience: 1 year (Required)

Shift availability:

• Day Shift (Required)

Work Location: One location

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