Company

Unifin SASSee more

addressAddressRochester, NY
type Form of workFull-Time
CategoryInformation Technology

Job description

QC Chemist

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.

Your role

Reporting to the Quality Assurance Supervisor,

JOB SUMMARY:
This position performs analyses ofmaterials, drug substances and drug products following cGMPs. Supports methoddevelopment activities and perform method validations with supervision.  Maintains and proposes improvements to labquality systems.

ESSENTIAL DUTIES / 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 toExecute 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.
Ensures documentation of training is retained as required by departmental procedures.

Your profile


REQUIRED EDUCATION: Associate's Degree (Bachelors preferred) inchemistry or related science
D.  QUALIFICATIONS/EXPERIENCE:
      A.A.S. with 5+ yrs. or B.S. with 2+ yrs.experience in chemistry or related science discipline.
E.  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.
ComputerSkills:
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:  (List the details of the environment within/under which work isperformed 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.

Compensation range

20,00 - 30,00 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.

 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!

  

Refer code: 7747486. Unifin SAS - The previous day - 2024-01-07 03:22

Unifin SAS

Rochester, NY
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