Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility as appropriate
- Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
- Performs laboratory operations with good dexterity good laboratory technique and high degree of accuracy and precision
- Perform/review preparations of reagents samples and standards according to procedures.
- Perform routine nonroutine and complex analyses; instrumental analyses; including calibration and troubleshooting/repair of instruments independently
- Make technical decisions without consulting management
- Guide and mentor junior staff to successfully complete projects and grow technical knowledge
- Do independent research into regulatory trends and technical advances
- Be a technical resource for internal problems throughout ELLI
- Provide support for corporate initiatives through BPT network
- Provide coverage for management when needed
- Document testing observations deviations and results clearly and completely and in compliance with regulatory requirements striving to minimize errors
- Understand and perform calculations as required by test methods
- Understand and utilize computers for information access calculations and report preparation
- Read and understand analytical procedures (compendial and client supplied) and internal SOPs
- Assist with onboarding new instrumentation including performing/reviewing IQ/OQ/PQ data or qualifications
- Provide consultation for clients
- Demonstrate technical writing skills and complete investigations independently
- Demonstrate leadership qualities including;
- Effective communication
- Display confidence
- Demonstrate motivation and take initiative
- Follow through on assignments
- Process/review data generate/review reports and evaluate data
- Communicate effectively both orally and in writing
- Suggest and implement lab improvements or modify existing processes to maximize quality and productivity; support and drive LEAN initiatives
- Support or identify speaking or publishing opportunities and assist with driving to publication or presentation
- Commitment to occasional overtime as workload requires
Qualifications :
- Bachelors degree in chemistry biology biochemistry or related degree concentration and a minimum of 8 years of laboratory experience masters degree with a minimum of 5 years of laboratory experience or a Ph.D. with a minimum of 3 years of laboratory experience
- Run the instrumentation independently including but not limited to various chromatographic systems UV/Spec various wet chemistry analyses HPLC GC ICP FTIR IC DSC and dissolution apparatus
- 5 years of experience using chromatography or ICP in a cGMP environment
- Experience in a cGMP GLP and/or ISO 17025 compliant/accredited lab.
- Experience with set up and validation of new analytical techniques and instruments
- Preparation of standards and samples for analysis
- Writing technical documents for experiments
- Execute method validation and transfer protocols
- Document work as required for GMP compliance
- Perform monthly maintenance of laboratory equipment
- Good dexterity; positive attitude; solution driven; good work habits (organized efficient careful safetyconscious accurate); attention to detail; sound scientific logic; good oral and written communication skills; understanding of multiple instrumentation platforms and/or instrumental theory; client service focused; demonstration of organizational skills; ability to independently work on complex projects; ability to multitask; technical writing skills
Additional Information :
This is an onsite position in Lancaster PA and is fulltime (MondayFriday 8 a.m.5 p.m. with overtime as needed.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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All your information will be kept confidential according to EEO guidelines.
Eurofins USA BioPharma Services is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime