As an Aseptic Sampler (3rd Shift) you will be responsible for collection of environmental monitoring samples. Assume delegated responsibilities for group personnel training, scheduling, and maintaining/ordering of supplies and equipment. 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Perform Environmental Monitoring duties related to viable air, viable surfaces, swabs, and non-viable air sample collection
Coordinate 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, order equipment to perform all monitoring
Maintain equipment in good working condition in a calibrated status
Handle special projects such as abnormal test results, validation studies
Assure 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 and assist the training of new personnel
Participate in development of training programs and conduct training sessions for new and less experienced staff
When assigned to rotating shift work; 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
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives
We are looking for professionals with these required skills to achieve our goals:
B.S. in Biology, microbiology, biology or related field
If you have the following characteristics, it would be a plus:
2+ years experience in quality control or production within the pharmaceutical or biotechnology industry
Experience with standard aseptic technique
Experience with Office of Health & Safety (OHS) Medical Guidance for working in production environment
Computer skills required in Excel and Word
Experience with following written procedures and document results in a neat and precise manner
Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; over-time may be required
Experience with being well organized, flexible, open-minded and dynamic
Experience with demonstrated self-direct work habits and strong communication skills
Experience with being a committed team player prepared to work in and embrace a team based culture
Experience with working within a multi-skilled team
Maintaining attention to detail, while completing multiple or repetitive tasks
Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
Maintaining 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. Solid team player able to function within team based organization
Experience in interacting with peers, subordinates and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA and QC
Experience with prioritizing and deciding appropriate course of actions
Experience with understanding client's needs (producers) and to interact with people from various domains (Regulatory, QA, other analytical groups inside the Company.)
Experience with performing all job duties with limited supervision
Demonstrated familiarity with cGMP's, facility regulatory guidelines and standard operating procedures
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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