QC Laboratory Technician II

Description

Natureplex is seeking an experienced QC Laboratory Technician II to support our Quality Control team in an FDA-regulated OTC pharmaceutical manufacturing environment. This position is responsible for sampling, inspecting, testing, and documenting raw materials, in-process materials, and finished products to ensure compliance with established specifications, cGMP regulations, and company quality standards.

The ideal candidate is detail-oriented, organized, and experienced in pharmaceutical or other FDA-regulated manufacturing environments, with a strong understanding of laboratory testing, documentation, and quality systems.

• Sample incoming raw materials, packaging components, and in-process materials in accordance with approved procedures.
• Perform raw material identity testing using approved laboratory techniques and instrumentation.
• Conduct physical testing of raw materials, in-process samples, and finished products.
• Review Certificates of Analysis (CoAs) and verify compliance with internal specifications.
• Accurately document laboratory testing in accordance with cGMP, ALCOA+, and data integrity requirements.
• Support investigations involving out-of-specification (OOS), out-of-trend (OOT), deviations, and CAPAs.
• Calibrate, verify, and maintain laboratory equipment.
• Prepare laboratory reagents, standards, and reference materials.
• Maintain laboratory inventory, cleanliness, and organization.
• Assist with internal, customer, and regulatory inspections.
• Support continuous improvement initiatives and revision of laboratory procedures.
• Perform other duties as assigned.

Requirements

• Associate degree in Chemistry, Biology, Chemical Technology, or a related scientific discipline (Bachelor's degree preferred).
• Minimum three years of Quality Control laboratory experience in a pharmaceutical or other FDA-regulated manufacturing environment.
• Experience performing raw material inspection and physical testing.
• Knowledge of cGMP regulations and laboratory documentation practices.
• Experience with Microsoft Office applications.
• Strong analytical, organizational, and communication skills.
• Ability to work independently while maintaining a high level of accuracy.

• Experience using NIR, FT-IR, or other raw material identity testing equipment.
• Experience with LIMS or electronic laboratory documentation systems.
• Familiarity with HPLC, GC, UV-Vis, or similar analytical instrumentation.
• Experience supporting FDA inspections.
• Experience with OOS investigations, deviations, CAPAs, and SOP development.

• Competitive compensation
• Medical insurance (Natureplex pays 80% of employee premiums and 20% of dependent coverage)
• Dental and Vision Insurance
• Company-paid Life Insurance
• Short-Term Disability
• Voluntary Life Insurance
• 401(k) eligibility
• Paid Vacation
• Paid Holidays
• Opportunities for professional growth in a growing OTC pharmaceutical manufacturing company

• Full-Time
• Monday – Friday
• Overtime and occasional weekends as business needs require

Natureplex is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable law.

Natureplex participates in E-Verify.