Quality Control Technician
SUMMARY: Performs testing, reviews test data, and writes investigations in compliance with cGMPs and SOPs.
DUTIES AND RESPONSIBILITIES:
- Analyzes products in compliance with cGMP regulations and SOPs.
- Test samples of raw materials and finished goods.
- Coordinate sending samples to outside testing facilities.
- Reviews, evaluates, interprets, summarizes, and presents data generated in support of method validation and stability studies; prepares technical reports and summaries based on data.
- Reviews data obtained for compliance to specifications; reports abnormalities.
- Completes and maintains appropriate documentation to support testing procedures and comply with GMPs including but not limited to data capture forms, equipment logbooks, and inventory forms.
- Calibrates and maintains laboratory equipment according to maintenance schedules, GMP requirements, and SOPs.
- Identifies and troubleshoots equipment problems.
- Assists with creation of new SOPs and/or revision of existing documentation.
- Reads, understands, and follows SOPs; complies with current GMP as required by FDA.
- Maintains supply levels for performance of assigned duties.
- Maintains accurate and updated laboratory notebooks and records.
- Participates in GMP audits.
- Follows all safety regulations.
- Performs other related duties as assigned by management.
QUALIFICATIONS:
· Bachelor’s degree (B.S.) in chemistry or related field.
· Three to five years related experience or equivalent
· Strong knowledge of GMPs, and product/process validation.
· Ability to develop clear, concise, and timely oral and written reports.
· Experience with laboratory environment, equipment and safety procedures.
· Experience in research and development
· Commitment to excellence and high standards
· Excellent written and oral communication skills
· Strong organizational, problem-solving, and analytical skills
· Ability to manage priorities and workflow
· Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
· Acute attention to detail
· Demonstrated ability to plan and organize projects
· Ability to work independently and as a member of various teams and committees
· Proven ability to handle multiple projects and meet deadlines
· Ability to work on complex projects with general direction and minimal guidance.
· Working knowledge of data collection, data analysis, evaluation, and scientific
method.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Occasionally required to stand
- Occasionally required to walk
- Frequently required to sit
- Continually required to utilize hand and finger dexterity
- Occasionally required to climb, balance, bend, stoop, kneel or crawl
- Frequently required to talk or hear
- Occasionally utilize visual acuity to operate equipment, read technical information, and/or use a keyboard
- Occasionally required to lift/push/carry items less than 25 pounds/ up to 25 pounds/ up to 50 pounds/ more than 50 pounds
- Occasionally work near moving mechanical parts
- Occasionally work around fumes, airborne particles, or toxic chemicals
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