• Follow site Standard Operating Procedures (SOPs) and Work Instructions (WI)
• Analyze chemical raw material samples.
• Analyze chemical bulk solution and finished goods samples.
• Maintain laboratory records (data integrity).
• Maintain laboratory histology instruments.
• Maintain a clean working environment.
• Perform laboratory and manufacturing instrument calibrations
• Initiate, revise and implement instrument and test method validation.
• Review and write/revise laboratory SOP’s on a continuous basis.
• Analysis of customer complaints including written report.
• Compliance with all company policies and procedures (safety, regulatory).
• Perform product stability testing/studies
• Complete project work as to support the organization (including sustaining engineering work)
• Participate in formulation development
• Participate in review of risk analysis for product development
• Lead and participate on Practical Process Improvement teams.
• Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
• Ability to work independently and as part of a team, self-motivation, adaptability and positive attitude.
• Familiarity with Quality Systems regulations.
• Associates Degree and/or 5-7 years of relevant work experience • Histologist Certification (HT) preferred • Experience supporting a manufacturing environment • Must be willing to work with and around hazardous chemicals. • Experience of working with FDA regulated products desired (Medical Device/IVD preferred) (pharmaceutical, dietary supplement or food experience is acceptable). • Knowledge of ISO13485 / FDA QSR 21 CFR Part 820 / 803 requirements preferred, 21 CFR Part 110, 111 or 211 is acceptable. • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously • Less than 5% travel (US & International)
Non-Negotiable Hiring Criteria: • 1-3 years laboratory experience in an FDA regulated laboratory • Proficient in MS applications (Excel, Word, Outlook) • Excellent communication and attention to detail • Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude
Nesco Resource is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Title 21 Of The Code Of Federal Regulations
Attention To Detail
Product Quality Assurance
Quality Management Systems