Proclinical is currently recruiting for a QC Laboratory Technician with a pharmaceutical company located in Marietta, PA.
- Perform entry level testing within the QC Lab. Scope includes retain inspections, entry level /microbiological testing and utility sampling.
- Perform routine laboratory tasks such as Utility/EM sample collections, execution of equipment work orders,, reading of environmental monitoring samples, bioburden testing, level one audits, daily pH meter and balance calibration, etc.
- Perform tasks associated with ordering laboratory supplies and maintaining laboratory equipment. Author SOPs and deviations.
- Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations.
- Identify atypical events or potential problems and communicate these situations with appropriate personnel.
- Perform utility sampling as per established procedures. Perform associated sample reads/testing.
- Generate all paperwork and labels associated with sampling to meet SOP requirements. Collect PEMS data.
- Perform EM sampling reading and microbiological tests in compliance with current SOPs and GMPs. All testing must be completed to satisfy established timelines and all applicable regulations.
- Author deviations and SOPs.
- Responsible for maintaining and ordering sufficient reagents and supplies, ordering equipment and maintaining the equipment in good working conditions in a calibrated and validated status. Performing routine laboratory tasks such as safety shower/eyewash checks, autoclaving materials, performing glass-wash and stocking supplies, daily pH meter and balance calibration, etc. Ensure labs are in a 'GMP, safe, analytical-testing readiness' state.
- Assure that all required documentation including records and logs, is complete and accurate according to the current GMPs. File and archive laboratory records and data in accordance with GMPs and SOPs.
- Communicate and report status of operations as well as variances to supervisors. Take appropriate actions and escalate issues immediately.
Skills and Requirements:
- S. preferred
- Prefer two years GMP laboratory experience (microbiology) or Assoc. or B.S. with minimum of one year GxP experience
- Computer skills required in Excel and Word.
- Ability to follow written procedures and document results in a neat and precise manner.
- Proficient with SAP.
- Must be well organized, flexible, open-minded and dynamic.
- 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.
- Position may require employees to work in a rotational schedule. This schedule will include participation in a non-routine business hour rotation to cover utility sampling collection on evening and weekends. This will require being on-call approximately one weekend a month. Some over-time may be required.
- Some experience in analytical systems including quality control, validation, documentation and compliance preferred.
- Strong interpersonal skills. Solid team player able to function within team based organization.
- Able to interact with peers, subordinates and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
- Demonstrated familiarity with cGMP's, facility regulatory guidelines and standard operating procedures..
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.