QC Sampling & Inspection Technician

About the role

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible. The QC Sampling & Inspection Technician performs sampling and inspection of incoming drug substances, raw materials, and packaging components while following applicable SOP’s and cGMPs.

Responsibilities

• Performs routine sampling of raw materials and packaging components following applicable SOP’s and cGMPs.
• Performs utility sampling for purified water, water for injection, and pure steam.
• Analyzes the results of inspection tests to ensure conformity to specifications.
• Maintains and stocks supplies required to complete sampling and inspection activities.
• Identifies and communicates actual and potential problems.
• May support/provide input for investigations and troubleshooting, with supervision.
• Writes basic investigations with some assistance.
• Able to gown to aseptic gowning standards
• Performs data entry and fills out paperwork following applicable SOP’s and cGMP/GDPs ensuring accuracy.
• Reviews colleagues work for accuracy in accordance with SOP’s and cGMP/GDP requirements.
• Maintains and updates training records in timeframe required by applicable procedures.
• Monitors and maintain equipment certification/calibration schedules
• Writes and participates in investigations as required

Qualifications

High School Diploma/GED required with 2-5 years of experience in a regulated environment, or an Associates Degree with 1-2 years of experience in a regulated environment. Experience with sampling and aseptic techniques. Experience in a cGMP environment. Experience in written documentation practices.

Skills

• Ability to read, communicate and legibly write in English.
• Strong math skills, with attention to detail.
• Ability to quickly learn and demonstrate comprehension of cGMP’s and SOP’s.
• Computer Skills: Basic Outlook skills, Basic Microsoft Word skills, Basic Excel skills.
• Familiarity with LIMS systems and inventory management systems (i.e. SAP) desirable.

Physical Requirements/Environment

Must demonstrate visual acuity, color recognition, finger dexterity. The ability to read, write and communicate in English. Work responsibilities involve chemical and biological agents that have assigned biological and chemical hazards. Sitting approximately 30% of day and standing/walking approximately 70% of day. Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation. Occasional lifting of up to 50 pounds. Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics. Occasionally subjected to weekend, holiday, and irregular hours.

Pay

Compensation Range 23.00 - 26.00 USD. The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility