QA Specialist I — Pharma Quality & Compliance

ANI Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 54,000 - 78,000; Full time

Job summary

ANI Pharmaceuticals, Inc. is seeking a Quality Assurance/Control professional to assure documentation quality and batch record disposition for raw materials, packaging components, finished product release, and stability documents at our Baudette, MN facility.

The role supports Manufacturing and Packaging operations, ensuring procedures align with cGMP requirements. Candidates should have a Bachelor’s degree and 2 years in QA/QC, with strong data interpretation and communication skills.

Qualifications

• Bachelor's degree and 2 years experience in Quality Assurance or Quality Control.
• Good understanding of laboratory testing and raw data, particularly HPLC.
• Previous work in a regulated environment.
• Ability to coordinate multiple tasks in a fast-paced environment.
• Ability to read and follow procedures.
• Ability to work independently as well as within a team environment.
• Excellent interpersonal skills.
• Excellent organizational and follow-through skills.
• Excellent written and verbal communication skills.
• Knowledge of cGMPs.

Responsibilities

• Assure the quality of documentation and data and disposition of batch records for raw materials, packaging components, finished product release and stability documents.
• Support Manufacturing and Packaging operations to ensure procedures are followed and meet cGMP requirements.
• Review data and reports for compliance with SOPs and FDA guidelines; highlight GMP deficiencies and initiate corrective actions.
• Assist in stability department activities, validation activities, and annual report assembly.
• Perform disposition of finished product, raw materials, and packaging components; review finished product stability data.
• Perform packaging line inspections/audits to ensure SOP and cGMP compliance.
• Inspect finished product attributes and evaluate physical characteristics prior to packaging.
• Monitor GMP areas for compliance with general GMP requirements and CFR guidelines.
• Other duties as assigned.

Skills

HPLC

Regulated environment

Procedures

Teamwork

Interpersonal skills

Organization

Communication skills

cGMP knowledge

Travel willingness

Education

Bachelor's degree

Job description

ANI Pharmaceuticals, Inc. is seeking a Quality Assurance/Control professional to assure documentation quality and batch record disposition for raw materials, packaging components, finished product release, and stability documents at our Baudette, MN facility.

The role supports Manufacturing and Packaging operations, ensuring procedures align with cGMP requirements. Candidates should have a Bachelor’s degree and 2 years in QA/QC, with strong data interpretation and communication skills.