Quality Lab Compliance Specialist (49323)

RAINING ROSE INC-posted 4 days ago
Full-time • Mid Level
Onsite • Cedar Rapids, IA
251-500 employees
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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.

  • 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.
  • Assist with Quality Control testing as needed.
  • 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.
  • Support audit readiness and participate in internal and external audits as needed.
  • Contribute to continuous review and improvement of processes to ensure consistent, efficient, and effective practices. Make suggestions regarding procedures, standards, and equipment to facilitate work and maintain product quality.
  • Firm understanding and compliance with company’s Good Manufacturing Practices (GMPs)
  • Display and promote company values (ASPIRE: Attitude, Safety, Passion, Integrity, Relationship, and Evolve)
  • Regular attendance
  • Other duties as assigned
  • Strong written and verbal communication skills with prevalent professional demeanor
  • Highly motivated
  • Ability to work in fast paced, rapidly changing, and regulated environment
  • Excellent planning and organizational skills
  • Ability to identify problems when they arise and notify appropriate personnel
  • Exhibit sound and accurate judgment
  • Ability to work effectively across departmental teams
  • Demonstrated ability to learn and apply new approaches
  • Entry Level mechanical aptitude
  • Intermediate level troubleshooting skills on minor equipment issues
  • Fundamental laboratory skills
  • Mathematical aptitude
  • Strong understanding of weights and measures
  • Proficient in various computer systems and ability to learn new systems quickly
  • 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
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