Job Summary:

Under supervision, this position supports the raw materials group, sample monitoring, lab supplies inventory, contract lab liaison, data review, data trending, metrics reporting, reference standards monitoring, compendial pharmacopeia changes and department's training program.

Job Responsibilities:

Review data and creates summary reports to assure data compliance.

· Review data from analytical testing of API, excipients and components following compendial (e.g. USP-NF, EP, etc.) and internal validated methods.

· Review data from analytical method verifications, method validations and method transfers.

· Reviews chromatographic and other electronic data for data integrity assurance and reliability.

· Monitor analytical standards expiration dates. Functions will be to organize, evaluate and re-order reference standards.

· Ability to analyze and interpret the analytical data under minimum supervision.

· Interpret protocols, reports, specifications, standard operating procedures, and standard testing procedures.

· Timely communicate to supervisor(s) the obtained data and any issues aroused during testing.

· Follow company’s SOPs, STPS and comply with safety regulations.

· Writes/reviews protocols, reports, SOPs and STPs using change control process under supervision.

· Coordinates sample transfer to contract laboratories.

· Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.

· Assist in controlled substances transfers, transactions, and annual inventory.

· Responsible for the raw materials annual report.

· Performs all work in accordance with all established regulatory and compliance and safety requirements.

· Other duties as assigned.

Job Skills:

· Ability to apply basic and intermediate mathematical operations.

· Ability to read, write and communicate in the English language.

· Interpret and follow company policies and procedures.

· General understanding of HPLC, GC, Drug Release, UV, IR, Titration.

· Use of common computer software and analytical applications programs, including but not limited to MS Word, MS Access, MS Excel, Chromatographic Acquisition (e.g. Empower), Adhesion Physical Properties(e.g. Bluehill, Exponent, etc.), Investigational and Document Control software (e.g. Trackwise), Stability Management software and LIMS.

· General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, correlation techniques.

· Knowledge of FDA, cGMPs, ICH Guidelines, and SOPs related to job requirement.

Job Requirements:

Education

· Bachelor's degree (B.S.) in chemistry or related field with at least 2-5 years’ experience in pharmaceutical laboratory, or master’s degree (M.S.) with at least 0-3 years’ experience.

Job Type: Full-time

Pay: $19.56 - $23.56 per hour

Benefits:

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

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Weekends as needed

Ability to Relocate:

• Miramar, FL 33025: Relocate before starting work (Required)

Work Location: In person