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Chemist II

Pharmaceutical Specialties -
Rochester, MN

Apply Now

Job Details

Full-time
$70,000 a year

Benefits

Profit sharing
Health savings account
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off
Life insurance

Qualifications

Technical editing
Microsoft Word
Stability testing
Content creation for technical audiences
Laboratory equipment performance testing and validation
Stability studies in drug product development
Technical documentation
Pharmaceutical regulatory compliance
Laboratory instrument validation
Word embeddings
Technical writing experience within manufacturing
English
Laboratory test results documentation
Data integrity and documentation
Laboratory reports
Bachelor's degree
Pharmaceutical company experience
Pharmaceutical analysis
Pipetting
Verification of laboratory test methods
GMP for research safety and compliance
Test validation method
Industrial chemical handling
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

Available Position

Chemist II

The Chemist II position responsibilities include both physical and chemical tests on raw materials and finished products according to Current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) requirements, the Food and Drug Administration (FDA) and Pharmaceutical Specialties, Inc. Standard Operating and Analytical Procedures.

ESSENTIAL JOB FUNCTIONS

Perform physical and chemical tests on raw materials and finished products:
- Infrared Spectroscopy
- UV-Vis Spectroscopy
- pH
- Titrations
- Quantitation
- HPLC
- GC
- Viscosity (Rheology)
- Specific Gravity
- TOC
- Wet chemistry
- ICP-OES

Be able to follow Standard Operating Procedures (SOP).
Document work in a clear and organized manner.
Be accountable for the accuracy and validity of test results.
Follow hygiene and safety rules for the Quality Control laboratory and other departments.
Maintain a clean lab and assists in purchasing.
Understand and perform IQ/OQ/PQ and calibration of equipment.
Develop and validate analytical methods (ICH/USP compliant)
Assist with new methodology for raw materials and finished products.
Author and execute method validation protocols and reports.
Be able to assist with new methodology for raw materials and finished products.
Author and edit SOP’s.
Pipetting skills are required.
Weighing skills are required.
Must be able to handle chemicals, including strong acids and bases, safely.
Execute stability protocols including testing.
Performs related duties as assigned.

COMPETENCIES

Experience in the area of Pharmaceutical/Cosmetic Chemistry preferred.
Analytical laboratory experience is required.
cGMP experience is required.
Experience with Quality Control testing is preferred.
Experience with advanced analytical techniques is required.
Experience with analytical method validation activities is required.
Able to use judgement to make decisions in carrying out assignments that have impact on safety, quality, regulatory compliance and brand value for PSI and its clients.
Be self-motivated with ability to work independently with a strong sense of good judgement.
Good communication skills and the ability to work with multiple departments.
Able to multi-task between routine testing and other projects.
Experience revising and authoring technical documents is required.
Proficiency in MS Word and Excel required.
Proficiency in other laboratory computer systems, such as OpenLab, is preferred.
Experience with other computer systems, such as document management and equipment management is preferred.
Experience in statistical analysis preferred.

SUPERVISORY RESPONSIBILITY

There are no supervisory responsibilities for this position.

WORK ENVIRONMENT

While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and moving mechanical parts. The noise level in the work environment is usually moderate.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.

While performing the duties of this job, the employee may be required to sit and use hands. The employee will also be required to stand, walk, use hands and arms, talk and hear. The employee must occasionally lift and/or move up to 50 pounds. Specific vision requirements are good close vision and to be able to see color at close and far distances.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

USUAL WORKING HOURS

Monday – Friday, 7:30 a.m. to 4:30 p.m.
Capability to work extended hours if necessary.

TRAVEL

This position may be required to travel for educational purposes.

REQUIRED EDUCATION/EXPERIENCE

Bachelor’s degree in chemistry or related science with 2-5 years of GMP Pharmaceutical/OTC experience.
Master’s degree in chemistry preferred.
Demonstrated experience with:
- Method Validation
- Stability indicating methods
- Data integrity compliance
- Instrument Qualification
Strong knowledge of chromatography techniques
Experience writing technical reports

ADDITIONAL ELIGIBILITY QUALIFICATIONS

Must be able to work with Quality Assurance (QA) department, Research and Development (R&D) department, Production department and Regulatory Department.
Good communication skills, both written and verbal, are essential when working on interdepartmental projects.
Language skills- Must have the ability to read and speak English fluently, interpret documents such as directions, instructions, safety rules, and procedure manuals in the English language. Must be able to record written information accurately.
Must have the ability to apply common sense and understanding to carry out instructions furnished in written, verbal, diagram, or schedule form.

COMPENSATION AND BENEFITS

This position is eligible for all full-time benefits including:
- Health, Dental, Life, and Disability Insurance
- HSA, HRA, and Day Care Assistance Plans
- 401(k) Retirement Plans with Profit-Sharing
- Bonus opportunities
- Generous PTO and paid holidays
The starting salary for this position is $70,000 per year.

EEO STATEMENT

PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.

WORK AUTHORIZATION

Must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

OTHER DUTIES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice.

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analytical chemist jobs in rochester, mn

Chemist II

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