Job Description

POSITION SUMMARY

The Chemist will provide analytical support for QC testing of antibiotic products which include raw materials, in-process samples, stability samples, validation samples, product surveillance, and finished products according to Quality Assurance standard procedures, as assigned. Assist with development and validation of chemical assays. Assist with installing, validating, and trouble-shooting new and existing equipment, including automated systems, as assigned. Accurately generate and document all analytical test results per written procedures and corporate policies and support management in the evaluation and review of all test results and investigations as needed.

ROLES & RESPONSIBILITIES:

• Maintains the QC laboratories to comply with cGMP and US Antibiotics standards of safety, quality, and cleanliness.
• Follows all safety precautions and guidance from training sessions, chemical hygiene plan, MSDSs (Material Safety Data Sheets), and other technical literature and resources.
• Performs efficient and reliable analytical tests following validated procedures for raw material, in process, validation, product surveillance, finished product, stability, water, and environmental samples, as assigned.
• Documents all results in accordance with cGMPs and written procedures.
• Troubleshoots and solves problems with assays and laboratory equipment and reports all observations.
• Strictly follows written procedures to minimize analytical variability. Recommends any potential improvements or changes to methods and lab operations (changes implemented via the change control process).
• Interprets analytical results correctly, notifying supervision promptly of any situation that indicates analytical issues or product issues.
• Participates in analytical method validations or transfers as required.
• Performs satisfactorily on all analyst qualification studies, indicating technical proficiency.
• Plans, performs, and documents non-routine tests (or special studies) and investigations under the direction of supervisor and/or manager.
• 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.
• Maintains and improves proficiency of technical skills through training.
• Conducts special studies in accordance with protocols and direction of management. Prepares well-documented reports of results.
• Carries out other departmental duties as deemed appropriate by supervisor/manager.
• Reviews (i.e., validates) analytical test results for other laboratory personnel, as required.
• Assists supervision in conducting analytical failure investigations, as required, following all procedures.
• Calibrates and maintains assigned laboratory equipment as needed according to schedules and procedures, documenting all results.
• Assists with equipment qualification testing as required by management.
• Assists with sampling tasks as required.
• Ensures that testing of products manufactured at the facility is performed per approved procedures and appropriate regulations and those lab operations conform to company standards for safety and performance.
• Reports all test results and any concerns with accuracy of analytical data and/or any issues that may impact product quality, efficacy, safety, or purity.
• Supports production needs by efficient laboratory turnaround of samples with right-first-time testing.
• Evaluates test results versus established test criteria and/or product specifications.
• Must be able to follow procedures for investigative analytical results as required.
• Advises, in a technical role, less-experienced staff, notifying supervisor or manager of problems/issues or additional training needs.
• Initiates ideas for operational changes and continuous improvement in laboratory, within constraints of policies and procedures to improve cGMP compliance, efficiency, cost, and performance.
• Must be able to assure the accuracy and integrity of analytical results/documentation generated. Exercises careful attention to testing procedures, and sampling handling and preparation as to avoid known degradation failure modes for materials under test, and to documentation.

EDUCATION, WORK EXPERIENCE, CERTIFICATIONS:

• BS/BA degree in Chemistry (or related science) or equivalent related analytical experience.
• Minimum of 0-5 years of analytical experience in pharmaceutical industry and/or other scientific experience.
• Strong knowledge/experience of cGMPs in areas beyond QC laboratory.

KNOWLEDGE, SKILLS, AND ABILITIES:

Skills/Abilities:

• Demonstrate ability to perform a wide variety of chemical, instrumental, and chromatographic analyses in an efficient, reliable, and safety conscious manner.
• Advanced computer skills.
• Appropriate interpersonal and leadership skills
• Strong verbal communication skills and technical writing skills.
• Ability to prioritize and decide appropriate course of actions for routine issues.
• Ability to recognize possible compliance, technical, or safety-related issues and notify supervisor or manager promptly.
• Ability to suggest appropriate corrective and/or preventive action(s) and assist with implementation.
• Ability to work in a multi-disciplinary team environment
• Demonstrate visual acuity per SOP requirements

Required Knowledge:

• 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
• Understanding of equipment installation, validation, calibration, and troubleshooting, etc.
• Strong knowledge of cGMPs, USP and FDA’s laboratory related requirements.

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