Job Description

About Us

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.

Position Summary

This position is charged with independently performing laboratory procedures, as defined by governing Standard Operating Procedures, applying analytical experience and knowledge to prepare reports and procedures, and mentor entry level analysts.

Quality Control Chemists must successfully complete the following training: Policy and Standard Operating Procedures, Laboratory orientation and safety training, training on specialized equipment and test methodology, Analyst Certification.

Position Accountabilities

The following are essential job accountabilities:

1. 50% Perform laboratory testing on material and product samples. Prepare standards and samples in accordance

with approved procedures. Set-up and confirm suitable operation of equipment and instrumentation. Collect

data and generate/report results in accordance with governing test methods and SOPs. Report discrepancies,

and assist/mentor peers.

2. 25% Perform review of data collected under approved test methods and investigational plans and protocols, in

accordance with governing SOPs. Provide accurate assessment of data integrity, and document findings.

Work with peers to correct deficiencies, and assure understanding.

3. 10% Perform calibration, preventive maintenance, and repair as needed on assigned equipment. Update equipment

procedures to reflect proper usage and maintenance.

4. 10% Perform cGMP tasks as assigned such as monitor expiry dates, auditing documentation and logbooks, and

ordering supplies. Prepare PPA's, investigation reports, and Method/SOP/IOP revisions.

5. 5% Performs other duties as assigned or requested.

Job Specifications

Core Competencies

• Communication
• Competitive Drive
• Customer Service Orientation
• Integrity
• Safety
• Strategic Thinking
• Teamwork

Functional Competencies

• Data Affinity
• Project and Process Management
• Quality Standards and Best Practices

Minimum Education

• Bachelor's degree in Chemistry or closely related field/major.

Minimum Experience

• 2 - 5 years experience in an analytical chemistry lab in a Pharmaceutical or similarly regulated environment

Minimum Field-of-Expertise

• Ability to work independently
• Demonstrated expertise of Laboratory cGMPs
• Follow written procedures and perform technical writing.
• Organization, communication and interpersonal skills.

Physical Demands

• Ability to carefully handle fine glassware, sampling devices and perform data entry
• Ability to lift up to 20 lbs.

Preferred Education

• Post graduate education in the field of Chemistry, Pharmacy, or closely related field.

Preferred Experience

• 1 year of experience in ANI Pharmaceuticals analytical lab, and/or experience in testing methodology.
• 3 - 5 years experience in an analytical chemistry lab in a Pharmaceutical or similarly regulated environment.
• Experience developing lab procedures and systems preferable in a pharmaceutical or similarly regulated environment.

Travel

• Occasional travel

Working Conditions

• Laboratory Environment

The base salary range for this position is $48,000-$52,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.

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.