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GMP Monitor

Job Post Index 25889E-Sy##
Location Marietta, PA
Description: Description
  • Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations
  • Identify deviations and potential problems and communicate these situations with appropriate personnel.
  • Perform Environmental Monitoring duties related to viable air, viable surfaces, swabs, and non-viable air sample collection.
  • Coordination of daily sampling activities for environmental monitoring (including generation of sample collection paperwork, labels, sample submission, etc) to meet SOP requirements.
  • Responsible for maintaining and ordering sufficient supplies, maintain EM media inventories, ordering equipment to perform all monitoring, and maintaining the equipment in good working conditions in a calibrated status.
  • Handle special projects such as abnormal test results, validation studies
  • Assure that all required documentation including records and logs, is complete and accurate according to the current GMP rules.
  • Maintain required records and logs
  • Revise and write SOP’s specific to monitoring as required and assist/lead the training of new personnel.
  • Assist with and participate in development of training programs and conduct training sessions for new and less experienced staff
  • Work independently and without direct supervision to perform normal operating routines and emergency response procedures.
  • Communicate and report status of operations as well as variances from specifications to area manager.
  • Take appropriate actions and escalate issues immediately.
  • Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies,
Skills: Qualifications
  • Minimum B.S. in biology, microbiology, biology or related
  • 2 years of experience in quality control or production within the pharmaceutical or biotechnology industry
  • Knowledge of standard aseptic technique.
  • Computer skills required in Excel and Word.
  • Ability to follow written procedures and document results in a neat and precise manner.
  • Must be well organized, flexible, open-minded and dynamic.
  • Must have demonstrated self-direct work habits and strong communication skills.
  • Must be a committed team player prepared to work in and embrace a team based culture.
  • Ability to work within a multi-skilled team.
  • Maintain attention to detail, while completing multiple or repetitive tasks.
  • Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
  • Maintain a high level of integrity while balancing multiple priorities and responsibilities.
  • Some experience in analytical systems including quality control/production, validation, documentation, and compliance preferred.
  • Experience with SAP system
  • Strong interpersonal skills.
  • Able to interact with peers, subordinates and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA and QC.
  • Able to prioritize and decide appropriate course of actions.
  • Ability to understand client’s needs (producers) and to interact with people from various domains (Regulatory, QA, other analytical groups inside the Company.)
  • Familiarity with cGMP’s, facility regulatory guidelines and standard operating procedures.

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