Quality Control Chemist

SUMMARY

Perform equipment, cleaning and process validation activities, including the writing of protocols and reports and compiling data and attachments into comprehensive validation packages.

Essential Duties and Responsibilities

Responsible for assisting with the development of procedures, specifications, validation master plans and other validation and engineering related documentation.

• May also participate in design and build activities, equipment procurement, optimization and troubleshooting of equipment and processes.
• Analysis of raw materials, finished products and stability samples by HPLC/UV and other lab techniques.
• Analytical Method Validation as per regulatory guidance (ICH, FDA, USP, BP, EP etc.) for new formulations including but not limited to Tablets, Capsules, Gels, Pastes, Creams and Oral solutions/Suspensions.
• Review of analytical data.
• Perform method transfer activity with various customers.
• Perform various analytical tests to ensure product meets all specifications.
• Calibration of various analytical instruments (HPLC, Spectrophotometer, dissolution apparatus etc.).

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to apply comprehensive knowledge of pharmaceutical cGMPs and quality system controls, procedures and records to ensure ongoing quality compliance.

Ability to perform all requirements independently with limited managerial oversight.

Excellent organizational abilities to meet accelerated timelines, manage multiple shifting priorities and maximize efficiencies in a dynamic customer-focused environment.

Superior attention to detail to ensure accuracy of work product.

Superior critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.

Education and/or Experience

Minimum 3-5 years’ experience with working, understanding and developing HPLC methods, protocols and analysis using HPLC’s. And secondarily wet chemistry skills or having an understanding of USP/NF methodology.

Degree (BS or BA) in Biology, Chemistry, Biochemistry, or relevant related field. Sufficient technical depth or professional experience will be considered in lieu of technical degree.

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Philadelphia, PA 19115: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• developing HPLC methods: 3 years (Preferred)

Work Location: One location