Associate QC Chemist

Unifin SAS • Rochester, NY

61d • $22 - $25 • Onsite

About The Position

This position performs analyses of materials, drug substances and drug products following cGMPs. Supports method development activities and performs method validations with supervision. Maintains and proposes improvements to lab quality systems.

Requirements

• A.A.S. with 5+ yrs. or B.S. with 2+ yrs. experience in chemistry or related science discipline
• Experience with laboratory analytical techniques.
• Ability to operate & maintain HPLC systems and/or dissolution equipment and spectroscopic instrumentation (UV/Vis, FTIR).
• Experience in written notebook documentation practices.
• 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.
• Intermediate 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; as well as create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes.
• Intermediate 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, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts.
• Familiarity with LIMS and experience with instrument operating software.
• 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.
• Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

Nice To Haves

• Experience with HPLC method development & validation in pharmaceutical environment is desirable.

Responsibilities

• 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.
• Supports method development/validation and method transfer activities.
• Proactively identifies issues, communicates & proposes/implements solutions.
• Performs laboratory troubleshooting; proposes solutions, implements with direction.
• Supports investigations, proposes solutions. Writes investigations with supervision.
• Recommends and assists in implementation of improvements to procedures.
• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.
• Implements training that ensures our ability to meet GMP, regulatory, and customer requirements and promotes first time right delivery.
• Monitors the effectiveness of their training efforts and modifies approach to ensure achievement of learning objectives.
• Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.
• May support/provide input for investigations, troubleshooting, and method development/validation with supervision.
• Writes basic investigations with supervision.

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: Entry Level
• Education Level: Associate degree