Quality Control Chemist - Pharmaceuticals

MSN Pharmaceuticals Inc. (MSNPI) is one of the fastest-growing, research-based, generic pharmaceutical companies. Pro-active marketing, robust IP strategy, innovative R&D expertise and world class production capabilities are our ingredients for success. We value Integrity, Imagination and Innovation in a team-based work environment.

Job description

Your Role and Responsibilities include but are not limited to:

• Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures
• Maintain accurate record of analysis and perform documentation to company standards
• Prepare test solutions, volumetric solutions, and samples used in analysis
• Performs assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products analysis in an FDA regulated lab environment
• Uses a variety of analytical instruments such as HPLC, GC, Dissolution, Malvern, IR, Auto Titrator, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer etc.
• Perform analysis with a practical understanding of the test procedure and instrument operation
• Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results
• Conducts laboratory investigation under the supervision of laboratory manager.
• Performs maintenance and calibrations of laboratory instruments /equipment
• Complies with all regulatory/ in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation
• Perform analysis with a practical understanding of the test procedure and instrument operation
• Maintain required level of training needed to perform a GMP task
• Prepares and/or Reviews Test Procedures, SOP's and Protocols as assigned
• Notify manager immediately of nonconforming data or unexpected occurrences
• Organize work schedule to complete assigned tasks efficiently and on schedule
• Work under direction provided by supervisor and Other duties as assigned

Qualifications & Requirements:

• Bachelors Degree with at least 2 years of experience in Pharmaceutical Quality Control Laboratory required
• Knowledge of cGxP, FDA and GMP regulations, Quality Control Laboratory Instruments
• Experience in investigation writing skills,
• Experience in handling Liquid Formulation (Oral solutions, Suspension) is preferable.
• Ability to work independently as well as team environment
• Good communication skills and ability to collaborate with others, ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Knowledge of Safety and hazardous waste requirements, cGMP & cGMP standards, standard operating procedures, approved test methods and/or protocols, regulatory requirements.
• Analytical experience in a regulated Pharmaceutical industry, fast paced GMP/FDA environment
• Must be flexible with changing business needs and perform other duties as assigned.
• Authorization to work in the United States indefinitely without restriction or sponsorship

Physical Demands/Factors:

• While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to sit, walk, talk, hear, handle or feel tools or controls. The employee is occasionally required to reach with hands and arms, stoop, crouch, climb or balance, kneel. The employee must occasionally lift and or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision and peripheral vision.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Piscataway, NJ 08854: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Pharmaceutical Quality Control Laboratory: 1 year (Required)

Work Location: One location

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