Laboratory/Regulatory Technician

Qualifications:

EDUCATION

• Bachelor’s degree with a major in Science or related field is preferred

EXPERIENCE

• Laboratory experience required, micro analysis preferred.
• Excellent organization, record keeping and data entry skills required.
• Good computer skills (Word, Excel. Etc.).
• Strong written and verbal communication skills
• Knowledge of the use of pH meters, Brookfield viscometers and laboratory balances, FT-IR, specific gravity, tap density, moisture analyzer, among others is a plus
• Must be able to differentiate colors
• Must be able and willing to perform the same types of tasks on a daily basis (for the most, work is routine and repetitive)
• Understanding of the USP Pharmacopeia is a plus
• Experience in writing SOP’s is a plus

Responsibilities:

PRINCIPAL OBJECTIVES

• Organize, set-up and conduct stability testing of a wide variety of products, in accordance with SOPs and under the supervision and guidance of Director of Regulatory Affairs.
• Perform Micro analysis to incoming and outgoing product.
• Prepare stability samples when requested package stability.
• Maintain testing according to due date and calendar requirements.
• Update all stability results in laboratory notebook and electronically in a timely manner. Maintain neat, orderly and legible records.
• Evaluate stability samples and results.
• Provide data and samples to Director of Regulatory Affairs for review at each time point.
• Communicate formulation stability results and issues promptly and thoroughly to the responsible Manager (as requested).
• Assist in the general maintenance and upkeep of Stability laboratory and storage areas.
• Must be able to write Standard Operating Procedures.
• Knowledge in USA/EU food, cosmetics and drugs regulations is preferred.
• Handle other projects and duties as assigned. Interpret test results and investigations.
• Conduct all activities with high quality, complying with SOPs and cGMP requirements.
• Assist in the maintenance of laboratory instruments, raw materials, packaging components, glassware, supplies and waste removal.
• Maintain an organized, clean and tidy laboratory workspace.
• The worker will also be involved with company certifications agencies.
• Collect data needed for product registration with federal, state and other regulatory agencies.

PHYSICAL REQUIREMENTS:

• Worker must be able to lift and move objects up to forty pounds as required by laboratory raw material handling and waste disposal practices.
• Worker is expected to remain standing for sustained periods of time while working at the lab bench and in the laboratory setting.

WORKING CONDITIONS:

• Work is performed in a laboratory and office setting.
• Worker is not exposed to adverse environmental conditions.
• The worker will be working with chemicals and expected to wear safety glasses and appropriate personal protective equipment (lab coat, gloves, etc.) and use exhaust hood when needed.
• The worker is expected to have good lab practices and high regard for safety.

COMPENSATION:

• Competitive Salary
• PTO
• Health Insurance
• 401K
• Full Time work week schedule : 35 hours a week from 8am until 4pm

Job Type: Full-time

Pay: $35,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off