QA/QC Technical Specialist

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies.  We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

Provide technical support for QA, QC, and TS laboratories. Primary responsibilities include creating validation protocols, equipment validation (IQ, OQ, and PQ), equipment calibration, and manufacturing process troubleshooting, in addition to supporting Annual Product Review documentation. Accurately document all work per written procedures and support improving the effiency and compliance status of the laboratories.

ROLES & RESPONSIBILITIES:

•Encourages safety first in work practices via guidance from training sessions, chemical hygiene plan, MSDSs (Material Safety Data Sheets), and other technical literature and resources

•Troubleshoots analytical and manufacturing processes and reports problems/resolutions to impacted area

•Maintain laboratories to comply with cGMP and USAntibiotics’ standards of safety, quality, and cleanliness

•If needed, provides statistical support for annual product reviews, special studies, investigations, validation projects, regulatory submissions, etc.

•Supports activities for the QC Laboratories such as instrument qualifications, calibrations, and maintenance as needed according to schedules, training, and procedures.

•Perform analyst qualification studies, indicating technical proficiency to support troubleshooting analytical testing

•Support any special studies as needed in accordance per protocols and direction of management. Prepares well-documented reports.

•Advises management of any potential improvements, ideas, or changes to methods.

•Assists with technical writing as required, e.g., revision of analytical procedures, equipment related SOPs, results summaries, initiates change request as required.

Evaluates and utilizes state-of-the-art equipment, including automated systems and computerized systems to perform and document testing and meet the goals of improved performance, including reliability and efficiency

•Assists the Quality unit in meeting goals, business objectives, and production plans

•Propose ideas for operational changes in QA, QC, and TS laboratory to improve cGMP compliance, efficiency, cost, and performance

•Create technical documents such as change controls, validation protocols (equipment, facilities, and cleaning), and summary reports •Keeps current with technical and professional literature and compendia, attending technical discussions, and training opportunities

•Assists QC Unit in conducting analytical failure investigations, as required, following all procedures

QUALIFICATIONS – EDUCATION, WORK EXPERIENCE, CERTIFICATIONS:

•BS/BA degree in Chemistry (or related science) or equivalent related analytical experience

EXPERIENCE REQUIRED:

•Minimum two (2) years of analytical experience in pharmaceutical industry or related technical scientific work experience

•Strong knowledge/experience of cGMPs in areas beyond QC laboratory

KNOWLEDGE, SKILLS, AND ABILITIES:

•Knowledgeable of a wide variety of laboratory equipment, testing procedures, GMP practices and maintain a safety conscious manner

•Advanced computer skills

•Appropriate interpersonal (team work) and leadership skills

•Strong verbal communication skills and technical writing skills

Ability to prioritize and decide appropriate course of actions routinely •Ability to implement decisions per instructions and guidance

•Ability to recognize possible compliance, technical, or safety-related issues and notify management promptly Ability to suggest appropriate corrective and/or preventive action(s) and assist with implementation, as needed

•Ability to work in a multi-disciplinary team environment

•Demonstrate visual acuity per SOP requirements

REQUIRED KNOWLEDGE:•Thorough understanding of analytical techniques, test methodology, method development, method validation and reporting for data integrity

•Comprehensive skills related to chemical, instrumental, chromatographic analysis, Operational Excellence, statistical applications and tools

•Thorough understanding of equipment installation, validation, calibration, and troubleshooting, etc.

•Strong knowledge of cGMP, USP and FDA’s laboratory related requirements​

TRAVEL REQUIREMENTS & WORKING CONDITIONS:

•The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

•While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell.

•The employee must frequently lift and/or move up to 50 pounds.

•Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

EEO Statement

USAntibiotics is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.