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 Associate's 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.
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.
A Smarter Total Compensation Package
At Unither, your base salary is just the beginning. Our Total Rewards include:
It’s a package designed to reward impact—not just hours worked.
More Than Just a Paycheck
At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!
Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Unither Pharmaceuticals is a pharmaceutical company specializing in the development and manufacturing of generic and branded pharmaceutical products.