Associate QC Chemist

Associate QC Chemist

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 QC Supervisor - Finished Products,

JOB SUMMARY:

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

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:

Completed Analysis

• 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.

Methods & Validation

• Supports method development/validation and method transfer activities.

Problems Identified & Resolved

• 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.

Safe, Compliant, Efficient Labs

• Supports lab systems as assigned and maintains laboratory in compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.

Trainees Demonstrate the Ability to Execute Analytical Processes

• 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.

Your profile

QUALIFICATIONS/EXPERIENCE:

A.A.S. with 5+ yrs. or B.S. with 2+ yrs. experience in chemistry or related science discipline

SPECIFIC SKILLS:

• Experience with laboratory analytical techniques.
• Ability to operate & maintain HPLC systems and/or dissolution equipment and spectroscopic instrumentation (UV/Vis, FTIR).
• Experience with HPLC method development & validation in pharmaceutical environment is desirable.
• Experience in written notebook documentation practices.

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.
• 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.

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 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 weekends, holidays and irregular hours.

SCOPE OF DECISION MAKING: 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.

Compensation range

22.00 - 25.00 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:

• 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

• And more-because we invest in your health, your future, and your peace of mind.

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.