Sr. Quality Assurance Associate LOC : Cincinnati, OH

Sr. Quality Assurance Associate LOC : Cincinnati, OH

  • Posted on : 09-08-2023
  • Job Type : Full Time only
  • Salary : 100,000 - 200,000

Job Description:

Responsibilities:

  • Writes SOPs, protocols, validation plans and compliance documents for c GMP program.
  • Sets-up and oversees c GMP program for manufacture of Active Pharmaceutical Ingredients.
  • Acts as departmental resource for c GMP programs.
  • Oversees qualification of instruments, equipment, facility, clean rooms and computer hardware - software.
  • Interfaces with prospective clients on c GMP audits then responds in writing to findings.
  • Interfaces with FDA during audits.
  • Sets-up and organizes tracking program for equipment used in c GMP work.
  • Reviews and authorizes batch production records and quality control documentation.
  • Solves complex, non-routine analytical and product problems independently.
  • Performs compliance audits of suppliers, contract labs and vendors then writes audit reports.
  • Performs internal audits and ensures observations are corrected.
  • Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program
  • Trains staff in area of cGMP and maintains training records.

Requirements:

  • BS/BA in science with 1-3 years Quality Assurance cGMP experience or an Associate degree with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience.
  • High level of knowledge in cGMP guidelines as specified in ICH Q7A.
  • Knowledgeable in instrument, equipment, facility, clean rooms and software qualification - validation.
  • Experienced at writing qualification and validation plans for facilities, equipment and manufacturing processes.
  • Experienced in auditing suppliers, analytical contract labs and vendors.
  • Knowledge of annual product review and stability study protocols per ICH.
  • Solves complex, non-routine analytical problems.
  • Trains others in area of cGMP.
  • Very strong oral and written communication skills.


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