Job Summary:

Under general supervision performs review of analytical data for raw materials, components, standards, intermediate/finished products. Responsible for creating/revising Test Methods, Specifications, SOP’s, and other types of technical documentation. Maintain document databases and files.

Job Responsibilities:

• Performs release and stability data review for raw materials, components, standards, intermediates, and finished products.
• Writes Test Methods (STP’s) and Specifications based on technical reports, USP, EP, or other compendial monographs.
• Implements changes and revises laboratory documents as needed.
• Maintains control of original laboratory documentation and liaison with Quality Assurance staff for release of materials.
• Participates with Laboratory Supervisors and Analysts to originate and complete investigations for OOS and OOT reports.
• Reviews protocols and reports (e.g., validation, qualification) for accuracy.
• Works with Laboratory Supervisors to maintain product schedules.
• Writes data summaries and Certificates of Analysis for material release.
• Distributes new test methods and specifications, and accounts for previous versions.
• Serves as Subject Matter Expert for Good Documentation Practices in the laboratory.
• Initiates training for new procedures and test methods.
• Applies GMP principles to daily job functions.
• Participates in client and regulatory audits.
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant 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: From $75,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday
• Weekends as needed

Ability to Commute:

• Miramar, FL 33025 (Required)

Ability to Relocate:

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

Work Location: In person