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Perform routine and non-routine analytical laboratory tests on materials, drug substances, and drug products following cGMPs. Support method development, validation, and transfer activities while maintaining lab quality systems and equipment.
Requires an Associate degree with 5+ years of experience or a Bachelor's degree with 2+ years of experience in chemistry or a related science. Must be proficient in HPLC, spectroscopic instrumentation, and pharmaceutical documentation practices.
QC Chemist Associate
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 Andrew Bertolino,
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.
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:
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.
A world-leading pharmaceutical contract development manufacturing organization (CDMO).
Unither Pharmaceuticals, with 8 manufacturing plants (France, USA, Brazil and China) 4 commercial offices and 1 R&D platform, is the worldwide leader in sterile unit-doses contract manufacturing. Unither Pharmaceuticals manufactures several product lines, using highly innovative and competitive niche technologies such as: Liquid Stick-Pack, Sterile unit-dose (Blow Fill & Seal Technology), Multidoses with and without preservative, Pharmaceuticals bottles, Suppositories and Pessaries, etc. Our products are sold in more than 100 countries for an annual turnover of 371 million euros. Our vision is to be recognized for making affordable healthcare solutions that improve and simplify patients’ lives for as many people as possible. Our mission is to deliver innovative, competitive and sustainable solutions to our customers: pharmaceutical companies. Our promise is to consider patients’ needs in order to make successful products for our pharmaceutical customers.
Offices: 3-5 rue Saint-Georges, Paris, Ile de France 75009, FR · 151 rue André Durouchez, Espace Industriel Nord, Amiens, 80084, FR · Avenue Toussaint Catros, 33185, Bordeaux, 33185, FR · 755 Jefferson Road UNITED STATES, Rochester NY, NY 14623, US · Avenida Mario de Oliveira, Barretos, São Paulo 14781-160, BR
There are currently 89 open manufacturing positions in City of Rochester, NY listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include L3Harris Technologies, Atalys, Alsco Uniforms, University of Rochester, AMETEK, among others. Browse the listings above to see every active employer.
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