Technical Operations Specialist
Proclinical is currently recruiting for a Technical Operations Specialist with a pharmaceutical company located in Philadelphia, PA.
- Execute NCE investigations ensuring complete and thorough review and timely closure (target <30 days from initiation).
- Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands 'why' behind the regulations.
- Identifies, communicates, addresses and improves simple cGMP compliance and regulatory gaps and issues
- Performs basic analysis, interprets, and draws conclusion of scientific and process data per good document practices
- Identifies, participates, suggests with options, recommends path forward and leads basic decision making
- Follows and executes Standard Operating Procedures (SOPs)
- Revises, authors and provides comments as a reviewer to simple SOP
- Improves the efficiency and execution of SOPs
- Participates, provides information in the development of and authors basic technical documents such as non-conforming events, deviations, CAPA's, action plans and change controls
- Possess basic computer skills and able to efficiently use basic Microsoft applications
- Suggests, participates and implements continuous improvement ideas
- Participates, supports, presents and represents as an SME during regulatory inspections and client audits
- Interact frequently with support groups
Skills and Requirements:
- High School diploma and 2-4 years of relevant experience or Associates'/Bachelor's (science preferred) degree with 0-1 years of relevant or equivalent experience
- Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE).
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.
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.