QA Specialist I

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

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.

With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.

At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.

Responsibilities

This position will assure the quality of documentation and data, and assigned disposition of batch records for raw materials, packaging components, finished product release and stability documents. This position is also responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.

• Reviews data, including notebooks, data sheets, electronic data, ancillary data, logbooks, etc., as well as reports of results for compliance with corporate SOPs and FDA guidelines. Highlights GMP deficiencies, initiates the required documentation process, facilitates the implementation of corrective actions and monitor the resolution.
• Assisting as required in the stability department, with validation activities, and/or annual report assembly.
• Performs disposition finished product, raw materials, and packaging components. Performs review of finished product stability data.
• Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOP's and cGMP's.
• Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
• Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
• Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirement.
• Performs other duties as assigned or requested.

Qualifications

• Bachelor’s degree and 2 years experience working within 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 work within a team environment.
• Excellent interpersonal skills.
• Excellent Organizational and follow through skills
• Excellent written and verbal communication skills.
• Knowledge of cGMP's.
• Written and verbal communication skills
• Must be able to travel occasionaly.

The base salary range for this position is$54,000 - $78,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition, ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.

Job Info

• Job Identification 1392
• Job Schedule Full time
• Locations 210 Main Street West, Baudette, MN, 56623, US (On-site)