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Pharmaceutical Quality Assurance Chemist

2 months ago

Baudette, Minnesota, United States ANI Pharmaceuticals, Inc. Full time
Company Overview
ANI Pharmaceuticals, Inc. is a leading bio-pharmaceutical organization dedicated to providing high-quality branded and generic prescription medications to patients in need. Our commitment to excellence is reflected in our diverse portfolio and innovative approaches to pharmaceutical development and manufacturing.

Position Overview
The Quality Assurance Chemist role involves conducting independent testing within a pharmaceutical Quality Control laboratory environment. This position is essential for ensuring compliance with established standard operating procedures and testing methodologies. Responsibilities include testing raw materials, in-process samples, and finished products. The role also encompasses executing method validations, facilitating method transfers, and supporting the validation of new product development. Additionally, the chemist will be responsible for setting up and confirming the operational readiness of laboratory equipment and instrumentation, as well as collecting and reporting data in alignment with regulatory standards and internal SOPs.

Key Responsibilities
Responsibilities include, but are not limited to:
  • Reviewing data collected in accordance with approved testing methods and investigational protocols, ensuring adherence to governing SOPs.
  • Providing thorough assessments of data integrity and documenting findings accurately.
  • Conducting calibrations, preventive maintenance, and repairs on laboratory instrumentation as required.
  • Qualifying new equipment as assigned by management.
  • Executing cGMP tasks, including laboratory organization, documentation audits, and supply management.
  • Performing additional duties as assigned or requested by supervisory personnel.
Candidate Profile
  • Bachelor's degree in chemistry, biochemistry, microbiology, or a closely related field.
  • 1-3 years of experience as a QC Chemist, with a preference for candidates possessing 2-5 years of experience in a chemistry laboratory within the pharmaceutical, food, or related industries.
  • For Senior QC Chemist positions, 2-5 years of experience is required, with a preference for candidates having over 5 years of relevant experience.
  • Ability to comprehend and follow written procedures effectively.
  • Strong attention to detail and organizational skills.
  • Capability to work independently with minimal supervision.
  • Proficient problem-solving abilities.
  • Excellent communication and interpersonal skills.
  • Understanding of good laboratory practices and analytical methodologies.
Benefits & Perks
  • Comprehensive medical, dental, and vision insurance.
  • Life insurance coverage.
  • Short-term and long-term disability benefits.
  • Employee Assistance Program.
  • 401(k) retirement savings plan.
  • Generous paid time off and company-paid holidays.
  • Employee Stock Purchase Plan (ESPP).
  • Opportunities for career advancement within the organization.