Chemist II

Summary:

The Chemist II is responsible for knowing & following Good Manufacturing & Laboratory Practices as well as adherence to current USP methods, customer test methods and company policies and procedures for materials, products, test requirements, test methods, and customer requirements. The role requires detailed documentation and determining the disposition of incoming raw materials, supplied & manufactured bulk solutions, finished product, stability samples, validation samples and any other requested testing. Additionally, the Chemist II is responsible for ensuring that all required testing is performed and reported accurately, OOS results and investigations are reported immediately, and quality management system requirements are adhered to.

Primary Responsibilities:

• Document receipt of samples of raw materials, bulk solution and finished product.
• Identify item test specifications, test methods, test requirements & be able to reference current USP.
• Notify Lab Supervisor if P&P’s or test document forms do not reflect P&P’s current practice, FDA Requirements, customer requirements and USP requirements.
• Assure testing is performed as quickly as possible to avoid delays of product release for filling & shipping.
• Conduct method suitability and stability testing.
• Perform any work for support of validations-Cleaning &/or Process Validations.
• Responsible for obtaining samples and sending samples – if assigned
• Responsible for drafting and performing method verifications, validations, and transfers
• Responsible for stability program including writing protocols, managing schedule, and pulling samples for evaluation – if assigned
• Perform all work per current P&P’s and use current forms.
• Record results neatly, legibly and accurately.
• Forward all paperwork to Quality Lab Supervisor or trained designate for review
• Perform documentation to prove compliance to procedures and maintain paperwork/documentation so that it is readily available for audits.
• Notify Lab Supervisor immediately of any test results outside of the specification limits.
• Lead investigations for complex OOS/OOT results and non-conformances, authoring reports and contributing to root cause analysis and corrective actions.
• Maintain standards, reagents and equipment per current procedures & requirements.
• Maintain appropriate supply of laboratory reagents, standards and equipment and assure they are not contaminated nor expired or out of calibration.
• Keep lab equipment/dishes washed daily.
• Appropriately destroy any expired materials.
• Maintain Lab Equipment per current P&P’s.
• Perform calibrations in a timely manner – if assigned.
• Contribute to the evaluation, purchase, and qualification of new laboratory instrumentation and technologies.
• Perform daily, weekly, monthly, quarterly and annual duties as required.
• Ensure lab capability to support all required testing based on capabilities and customer expectations
• Recommend improvements where applicable. Monitoring changes to regulatory guidelines (e.g., USP, ICH, FDA) and propose updates to test methods or procedures accordingly.
• Manage special projects involving analytical support for new product introductions, process changes, or regulatory submissions.
• Other duties as assigned.

Supervisory Skills:

• This is not a supervisory position.

Language Skills:

• Ability to effectively present information (both verbal and written) to plant personnel, management and customers.
• Ability to read and interpret customer specifications.
• Knowledge of Good Manufacturing Practices.

Computer Skills:

• Microsoft Office
• OpenLab

Other Required Skills and Abilities:

• Above average math and measurement skills.
• Able to multi-task, prioritize projects and follow – up on issues.
• Detail oriented, able to catch mistakes.
• Well organized.
• Highly motivated.
• Able to work independently with minimum supervision.

Education Requirements:

·       4 year degree in Chemistry or equivalent Science related field, or 2 year degree with relevant work experience.

Physical Demands:

Working conditions are normal for a manufacturing environment and an employee must be able to successfully perform these functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to regularly sit, talk, hear, stand, climb stairs, walk, use hands and arms to manipulate, handle, reach and feel. Work may involve lifting of materials and product up to 40 pounds. The noise level in the laboratory, warehouse and the packaging floor is low to moderate, respectively.