Quality Lab Compliance Specialist

Description

SUMMARY

The Quality Lab Compliance Specialist serves as subject matter expert on good lab practices, testing methods, lab equipment, and specification management with relation to the quality laboratory as well as third party lab analytical testing for release.  The Quality Lab Compliance Specialist plays a key role in supporting the Quality Department and Raining Rose by ensuring smooth daily operations of the lab, maintaining compliance with cGMP and FDA regulations, and facilitating communication between the quality department, production, and internal and external customers. This position involves oversight of laboratory documentation, method validations, lab inventory control, and data reporting to support the analysis and timely release of results for raw materials, in-process, and finished products.

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 ability required.

 ESSENTIAL DUTIES AND RESPONSIBILITIES FOR QUALITY LAB COMPLIANCE SPECIALIST (include but are not limited to the following)

• Work with vendors to install new equipment, establish preventative maintenance protocol, and write instrumentation Standard Operating Procedures (SOPs)
• Ensure annual preventative maintenance visits are scheduled and completed on lab equipment.
• Calibrate, conduct routine maintenance, and troubleshoot laboratory instrumentation.
• Write and implement qualifications and validations for products and equipment relating to the quality laboratory including, but not limited to, High Performance Liquid Chromatography  (HPLC), and Microbiological testing.
• Review and approve third party laboratory validations and documentation as part of the new product development process.
• Evaluate and assign testing methods and specifications (raw materials, bulk and finished goods) and evaluate specifications as needed to ensure accuracy for new product runs.
• Manage Out of Specification (OOS) investigation and documentation process and lead applicable interdepartmental meetings on active investigations and OOS trends.
• Analyze facts or circumstances surrounding individual issues to determine what action should be taken as it relates to out of specifications and new product failures. Approve or reject procedures and specifications impacting the identity, strength, quality, and purity of the drug product.
• Maintain clear and accurate documents and records that meet good documentation practices and data integrity requirements.
• Manage and organize annual drug product stability and related testing within the quality lab and/or with third party labs as needed.
• Train quality technicians and other team members on good lab practices, test methods, and equipment use as applicable to each position.
• Maintain quality laboratory related Key Performance Indicators (KPIs) and share information with leadership monthly.
• Maintain lab inventory and ensure timely procurement of reagents, reference standards, and consumables.
• Assist with testing needs on new products, trials, and/or pilots as needed for R&D and Engineering testing. Actively participate in the new product development (NPD) process to manage product transition from NPD to production and product release as it relates to the quality department and quality laboratory.

Qualifications

REQUIRED SKILLS AND ABILITIES FOR QUALITY LAB COMPLIANCE SPECIALIST

• Strong written and verbal communication skills with prevalent professional demeanor
• Ability to identify problems when they arise and notify appropriate personnel
• Exhibit sound and accurate judgment
• Entry Level mechanical aptitude
• Intermediate level troubleshooting skills on minor equipment issues
• Fundamental laboratory skills
• Strong understanding of weights and measures

EDUCATION AND/OR EXPERIENCE FOR QUALITY LAB COMPLIANCE SPECIALIST

• Bachelor’s degree in relatable field required
• A minimum of 4 years’ experience in a relatable field preferred
• Knowledge and understanding of chemistry required
• Knowledge of research and development methods, techniques and understanding laboratory hazards required
• Knowledge of and experience with microbial testing preferred
• Experience using laboratory instrumentation including FTIR and UPLC preferred
• Knowledge of and experience with ISO 17025 Lab Practices or similar preferred
• Experience with a wide variety of measuring instruments and product development preferred
• Knowledge of and experience with a preventative maintenance program preferred
• Knowledge of GMP’s, OSHA rules and regulations preferred

PHYSICAL REQUIREMENTS/ WORKING ENVIRONMENT FOR QUALITY LAB COMPLIANCE SPECIALIST

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Sit an average of 3-4 hours per day
• Stand an average of 3-4 hours per day
• Required Movements:
  • Bend/Stoop – Rarely (1-2 times per day)
  • Squat – Rarely (1-2 times per day)
• Weight Lifted:
  • Up to 40 lbs – Rarely (5-24 times per month)
• Weight Carried:
  • Up to 20 lbs – Occasionally (5-24 times per week)
• Job requires being around moving machinery and equipment
• Job requires wearing personal protective equipment as necessary