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,
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.