Proclinical is currently recruiting for a Laboratory Technician with a pharmaceutical company located in Philadelphia, PA.
- Performs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines, and SOPs using appropriate laboratory techniques for the lab group assigned to.
- Performs laboratory support functions (e.g. materials stocking function) to help ensure lab is operational and contributes to the overall operations and to the achievement of departmental goals and objectives.
- Adheres to and understands the importance of Good Manufacturing Practices and standard operating procedures, including Good Documentation Practices.
- Performs basic Standard Operating Procedures (SOP's) revisions and Reagent Preparation Records as needed to accurately reflect testing procedures.
- Completes recording of data in instrument logbooks and lab cleaning forms to comply with regulatory requirements.
- Attend daily lab meeting on a regular basis and escalate issues/concerns at that forum to the supervisor for further investigation.
- Performs revisions to existing documents (e.g., BRs, RPs, SOPs) following the DCR process.
- Provides operational support for testing activities including reagent preparation, cleaning activities, and equipment maintenance.
- Supports technical transfer of assays from client to Technical Development to Operations; supports additional research level testing activities.
- Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required. Works with minimal supervision from supervisor or Technical Reviewer.
- Completes all requisite site-specific and job-specific training (e.g, Bloodborne Pathogens, Safety, GDP,
- Demonstrates technical knowledge and contributes to the overall operations.
- Contributes to the achievement of departmental goals and objectives.
- Understands the importance of the regulatory compliance requirements for the production of biologics.
- Authors Test Methods, Standard Operating Procedures (SOP's) and Reagent Preparation Records as needed to accurately reflect manufacturing processes.
- Ensures junior manufacturing personnel comply with standard operating procedures.
- Works on routine assignments as well as other assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.
- Normally receives no instructions on routine work and general instructions on new assignments.
- Contributes to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and company policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Skills and Requirements:
- Bachelors' degree with a major in Biology, Chemistry or related Science major including lab courses involving work with nucleic acids.
- Experience in aseptic processing techniques a plus.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- 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).
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors.
- Based on work assignment, may be recommended to have medical testing in accordance with the company's Occupational Health Program.
- Proficient in Verbal & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.
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.