Job Overview
Perform basic, intermediate, or advanced quantitative and qualitative analyses of pharmaceutical components, in-process material, finished goods, and/or stability product. Depending on the department, some functions may not be applicable.
Samples Tested
- Set‑up, adjustment, calibration and operation of laboratory equipment and instruments, including associated software.
- Preparation of solutions, solvents, and mobile phases.
- Accurate preparation, collection, weighing, and analysis of samples and reference standards, determining conformance to approved specification limits.
- Assist in basic investigations for out‑of‑specification/out‑of‑trend results.
Documentation Completed to Standards
Provide accurate and timely documentation of all procedures, calculations, and results.
Department Specific Functions
- LIMS entry, approval, and data release of products.
- Use of analytical balances, HPLC, GC, KF Titrator, IR, UV, pH meter, volumetric glassware.
- Perform wet testing such as assay titrations, colorimetric tests, TLC, heavy metals, and sieves.
- Flexibility to work in other laboratories based on business need.
- Follow established procedures using own discretion and judgment.
- Identify/Research new lab supplies and order current lab supplies.
- Identify and implement cost‑saving opportunities.
- Sustain laboratory housekeeping and identify improvement opportunities.
- Complete hands‑on and electronic training.
- Participate and lead area huddles or shift meetings.
- Perform other duties as assigned.
QC Technician Levels
- QC Tech I – Perform basic wet chemistry, preparation of reagents/solutions, and sample reconciliation following approved methods.
- QC Tech II – Experienced with some instrumentation and wet testing.
- QC Tech III – Expert in wet chemistry analysis and instrumentation analysis performed by laboratory; perform instrument maintenance and troubleshoot chromatography issues; trainer for proficiency areas; perform peer review, release of all products, participate in validations, and execute Gage R&R experiments; initiate and support investigations; identify method improvements and perform change controls; communicate technical information within lab and with other departments.
Minimum Requirements
- Education – High School Diploma or equivalent required. Bachelor’s degree in Chemistry, Biology, or related science preferred; Associate’s degree with equivalent education, experience, and competencies accepted.
- Experience – Tech I: Classroom or previous work experience in a science related field. Tech II: Working knowledge of chemistry required. Tech III: Minimum 1–3 years of experience in a cGMP facility.
- Skills – Basic arithmetic, reading, writing, and speaking at a basic level; computer skills including Word, Excel, and database software; understanding of cGMP, SOP, and DEA regulations; problem‑solving of moderate difficulty; self‑motivated and initiative; teamwork; attention to detail; ability to learn technical concepts rapidly.
Preferred Skills and Qualifications
- Basic functions of arithmetic: add, subtract, multiply and divide all units of measure.
- Basic reading, writing and speaking at a basic level.
- Basic computer skills.
- Ability to understand and apply cGMP, SOP, and DEA regulations.
- Problem‑solving of moderate difficulty.
- Self‑motivated, demonstrates initiative, able to make good decisions under pressure.
- Performs well as part of a team.
- Attention to detail and accuracy.
- Ability to learn and apply technical concepts rapidly.
Other Skills and Competencies
- Comply with company policies and procedures.
- Follow safe working practices.
- Participate in general site and departmental safety initiatives.
Organizational Relationship and Scope
- Attention to Detail / Focus – Thorough and precise in accomplishing a task through concern for all areas involved; double‑checks accuracy and provides timely information.
- Listening – Practices attentive and active listening; accurately restates opinions of others.
- Consistent Process Follow – Accurately checks processes and follows established procedures.
- Problem Solving – Rigorously connects information, organizes divergent data, develops contingency plans.
- Analytical – Uses systematic approach; logical, mathematical, and analytical skills.
- Technical Learning – Quickly learns new skills and knowledge.
Working Conditions
Physical and Visual Activities or Demands
- Involves sitting, walking, standing, reaching, talking, and hearing.
- May require exerting up to 50lb force occasionally.
- May involve standing or moving majority of the day; some tasks on desk/bench at a computer.
- Requires judgment of distance and space; ability to identify and distinguish colors; focus on objects up to 20inches.
- Requires focused mental and visual attention most of the time.
Environmental and Atmospheric Conditions
Typical laboratory work environment. Exposure to pure chemicals, raw materials, and product; safety precautions with lab coat, safety glasses, gloves, dust mask/respirator, and safety shoes as outlined in MSDS. Hazards include proximity to chemicals and solutions, exposure to dust, odors, cleaning solvents, noise, vibration, and poor ventilation. Some elements make conditions less desirable than typical office environment.
Schedule
Day shift, Monday‑Friday 8:00am – 4:30pm.
Salary and Benefits
Expected base pay range: $43,319.00 – $67,710.00. Base pay may vary based on job‑related knowledge, skills, and experience. Position eligible for bonus in accordance with applicable program. Bonuses awarded at the Company’s discretion. Relocation assistance not considered. Position not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship needs.
EEO Statement
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.