QC Chemist Associate

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 2,400 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.

About the role

Reporting to Andrew Bertolino, 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.

Responsibilities

• Performs, interprets, evaluates, and records routine and some non-routine analytical lab tests of materials, drug substances, and drug products following CGMPs.
• Executes protocols and experiments as written.
• Maintains instruments and equipment, including 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 transfer activities.
• Proactively identifies issues, communicates, and proposes/implements solutions.
• Performs laboratory troubleshooting; proposes solutions and implements with direction.
• Supports investigations, proposes solutions, and 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 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 appropriate solutions to performance problems.
• May support/provide input for investigations, troubleshooting, and method development/validation with supervision.
• Writes basic investigations with supervision.

Requirements

• A.A.S. with 5+ years or B.S. with 2+ years of experience in chemistry or a related science discipline.

Skills

• Experience with laboratory analytical techniques.
• Ability to operate and maintain HPLC systems and/or dissolution equipment and spectroscopic instrumentation (UV/Vis, FTIR).
• Experience with HPLC method development and validation in a pharmaceutical environment is desirable.
• Experience in written notebook documentation practices.
• Computer Skills:
  • Basic Outlook skills (creating/sending messages, address books, message handling, personal folders, scheduling appointments, meeting requests, managing tasks).
  • Intermediate Microsoft Word skills (producing business letters, tables, charts, spell check, tabs, page orientation, sorting, saving/organizing files, mail merge, page setup, headers/footers, indexes, tables of contents, search/replace, labels/envelopes).
  • Intermediate Excel skills (using workbooks, simple formulas, inserting/deleting data, charts, filtering/sorting lists, formatting data, linking data, page orientation, headers/footers, graphs/charts).
• Familiarity with LIMS and experience with instrument operating software.

Physical Requirements

• Must demonstrate visual acuity, color recognition, and 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 the day and standing approximately 50% of the 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.

Pay

Compensation range: $22.00 - $25.00 USD per hour. Individual annual salaries/hourly rates will be set within this range and determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise, and internal equity.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value).
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution.
• HSA contributions with wellness incentives.
• Annual performance bonuses and merit increase eligibility.
• No paycheck deductions for healthcare premiums (worth an extra $1 to $3.50 an hour compared to jobs where you pay part of the premium).

At Unither, our culture is based on five values: Respect, Responsibility, Trust, Courage, and Innovation. We are committed to bringing these values to life by granting employees a high degree of autonomy and encouraging their initiatives. We provide working conditions and an atmosphere conducive to development and the expression of potential. 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 ensuring equal employment opportunity for all applicants.