QC Chemist Associate

at  UNITHER PHARMACEUTICALS

WHO WE ARE?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 280 employees.

JOB SUMMARY:

Performs routine analyses of materials, drug substances and drug products following cGMPs. May support analytical method development & validation, and analytical troubleshooting under technical supervision. Assists with maintaining lab quality systems.

REQUIRED EDUCATION:

Associate’s Degree (Bachelor’s preferred) in Chemistry or related science

QUALIFICATIONS/EXPERIENCE:

A.A.S. with 2+ yrs. or B.S. with 0+ yrs. experience in chemistry or related science discipline.

SPECIFIC SKILLS:

Experience with laboratory analytical techniques preferred. Experience in a cGMP environment a plus.
Familiarity in 2 or more following areas: HPLC, GC, UV-VIS, FTIR, dissolution.
Experience in written notebook documentation practices a plus.
Write basic investigations with supervision.
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 and instrument operating software desirable.
PHYSICAL REQUIREMENTS/ENVIRONMENT: (List the details of the environment within/under which work is performed and physical requirements for this position.)
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 50% of day and standing approximately 50% of day.
Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.
Occasional lifting of up to 35 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.

ESSENTIAL DUTIES / RESPONSIBILITIES:

Completed Analyses (40%)
Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances and drug products following CGMPs.
Execute protocols, experiments as written.
Maintains instruments and equipment. Sets up instruments and conducts sample tests. Performs routine calibration of instrumentation. Ensures an adequate supply of test materials are available to perform daily testing.
Maintains and updates training records in a timely manner.
Safe, Compliant, Efficient Labs (30%)
Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
Problems Identified (30%)
Identifies and communicates actual and potential problems.
May support/provide input for investigations, troubleshooting, and method development/validation with supervision.
Writes basic investigations with supervision.