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Chemist I (3-6 month contract)

Society for Conservation Biology

Newtown Township (Bucks County)

On-site

USD 50,000 - 70,000

Full time

3 days ago
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Job summary

A leading company in conservation biology is seeking a Chemist I for its Quality Control department. The role involves performing routine testing of various materials to ensure compliance with quality standards, operating analytical instruments, and maintaining accurate documentation. Candidates should have a BS in Chemistry and prior experience with laboratory techniques, with a strong emphasis on adhering to cGMP and regulatory requirements.

Qualifications

  • 0-3 years of related experience preferred.
  • Working knowledge of analytical techniques required.
  • Good communication skills are essential.

Responsibilities

  • Perform routine analytical analysis of materials.
  • Document analysis following cGMP and FDA guidelines.
  • Maintain laboratory records and ensure compliance.

Skills

HPLC
Analytical methods
Laboratory techniques
Good verbal and written English
Excellent interpersonal and communication skills

Education

BS in Chemistry or related science field

Tools

HPLC
UPLC
GC
UV spectrophotometers
pH equipment
Titration equipment

Job description

Job DescriptionJob Description
Department

Quality Control

Job Title

Chemist I

FLSA Status

Exempt

1. Role Purpose:

The Quality Control (QC) Chemist I will be responsible to perform routine testing of incoming raw materials, packaging components, drug substances, in process samples, drug products, and stability samples in accordance with internal Methods of Analysis (MOA), compendial, and other test methods. Adherence to Standard Operating Procedures (SOP) and the United States Pharmacopoeia (USP) is required. Analytical techniques will include bulk/tapped density, pH, KF, titrations, dissolution, UV-VIS spectrophotometry, and other ancillary test methods, HPLC and other, as necessary.

Attributable, legible, contemporaneous, original, and accurate documentation is also required.

Work also needs to be completed in accordance with applicable FDA, OSHA, EPA, and DEA requirements.

2. Key Duties & Responsibilities:

  • Performing routine analytical analysis of raw materials, packaging components, drug substances and drug products using different compendial and KVK Tech test procedures in compliance with written, approved methods
  • Ensuring all instruments are calibrated before each use
  • Documenting all performed analysis using cGMP, USFDA and 21CFR211.194 guidelines.
  • Maintaining laboratory records including notebooks, logs, and other pertinent documentation
  • Following current Good Manufacturing Practices (cGMP), applicable Code of Federal Regulations (CFR)
  • Reviewing data for compliance to procedures and specifications
  • Completing all training prior to performing GMP activities
  • Adhering to the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) safety regulations.
  • Operating and calibrating, or performing Preventive Maintenance and routine trouble shooting on analytical instruments
  • Complying with FDA guidelines/Company Policies of Data Integrity
  • Working independently under general supervision and direction in compliance with cGMP
  • Performing other duties as assigned or delegated
  • Handling hazardous waste in compliance with company SOP and hazardous waste rules


3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

BS in Chemistry or related science field preferred

Experience Requirement

Number of Years

1-3 years

5. Technical competencies/ Certifications/ Licenses:

Technical competencies
  • Working knowledge of HPLC, UPLC, GC, Dissolution, AA, UV spectrophotometers, pH and titration equipment
  • Aptitude for application of analytical methods
  • Skilled in laboratory techniques
  • Good verbal and written English
  • Excellent interpersonal and communication skills


6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

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