QC Sampling & Inspection Technician

Unifin SAS • Rochester, NY

25d • $23 - $26 • Onsite

About The Position

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. Sampling will also include sampling utilities such as purified water, water for injection, and pure steam. This role will also provide sampling & incoming inspection support for development projects.

Requirements

• 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.
• 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.
• Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
• Basic Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files.
• Basic Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data.

Nice To Haves

• Familiarity with LIMS systems and inventory management systems (i.e. SAP) desirable.

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

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED