QC Analytical Chemist - Level 2 (Analytical Development)

COATING PLACE LLC • Verona, WI

10d • Onsite

About The Position

The primary purpose of the QC Analytical Chemist 2 is to provide support to the Production and Formulations Departments by analyzing a variety of compounds and complex sample preparations. Support will be provided by analyzing samples according to various procedures including, but not limited to, internal SOPs, specifications, analytical methods, compendial monographs, client procedures, research procedures, and protocols. The QC Analytical Chemist 2 is expected to understand internal procedures and reliably conduct analyses with limited supervision. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.

Requirements

• Bachelor’s degree in Chemistry or related field.
• Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities
• Experience with the use and troubleshooting of analytical equipment (HPLC, GC, and/or dissolution)
• Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.
• Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
• Ability to lift objects weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.

Nice To Haves

• Experience with a LIMS preferred

Responsibilities

• Ensures adherence to Coating Place Standard Operating Procedures, analytical methods, protocols, company standards, and applicable regulations
• Analyzes a variety of compounds and complex sample preparations.
• Assists with analytical method feasibility, validations, transfers, and/or verifications.
• Basic understanding and use of Empower software.
• Drafts and edits new or existing internal procedures and specifications with supervisory support
• Trained on at least one of the following: HPLC, GC, or dissolution
• Analytical Lead on one projects with guidance from supervisor
• Utilizes and maintains QC analytical instrumentation
• Communicates with Production, Formulations, and QA departments as required to meet project and analytical testing needs
• Documents in laboratory notebooks, forms, logbooks, and other quality control documents in accordance with cGMPs
• Performs basic review of quality control records to ensure compliance with internal procedures and cGMPs
• Assists in maintaining a clean, organized QC laboratory.
• Lifts/carries objects weighing up to 55 lbs.
• Follows all Coating Place’s safety practices, policies, and procedures.
• Employees at Coating Place work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Benefits

• Friendly work environment
• Medical, Dental, Vision, Life, AD&D, and Disability Insurance
• Pre-tax 401(k) and after-tax Roth 401(k) contribution options with company matching up to 5%
• Generous Paid-time Off - Accrue up to 17 days of PTO within the 1st year.
• Tuition Reimbursement Program
• $2,000 Sign-On Bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level