QC Sampling & Inspection Technician

QC Sampling & Inspection Technician

Who we are?

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.

As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

Your role

Reporting to the Microbiology Manager,

JOB SUMMARY:

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.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Raw Material and Packaging Components Compliance Verified

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

Documentation and Inspection/Sampling Environment Maintained to cGMP 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

Your profile

QUALIFICATIONS/

EXPERIENCE:

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.

KNOWLEDGE

SKILLS and ABILITIES:

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 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.

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.

SCOPE OF DECISION MAKING:
Decisions require some judgment.…