Lab Manager

Denver, CO

The Lab Manager is responsible for developing, implementing, monitoring, and improving Quality Systems, in addition to procedures, and standards for ongoing production and initiative delivery-in compliance with regulations for drug and cosmetic products.  The Lab Manager is a key role, fully accountable for ensuring quality standards are being upheld in the Quality Department and across the facility to ensure daily FDA compliance.  The Lab Manager is also responsible for leading all validation activities. Validation activities can include equipment, instrument, cleaning, and process validation. The job includes writing and coordinating protocols, reports, and compiling data/attachments into comprehensive validation packages. This role shall lead the development of procedures, specifications, validation master plans and other validation and engineering related documentation.

 

Date Posted:
9/13/2021
Salary:
Starting at $100,000

LAB MANAGER RESPONSIBILITIES:

  • Deliver project objectives in line with Regulatory requirements and Company Quality Standards.
  • Supports managing company Quality Management Systems (regulated by FDA).
  • Communicates quality standards to internal Stake Holders.
  • Write and update Standard Operating Procedures.
  • Support the approval of product labels according to FDA labeling standards.
  • Work with other groups to validate drug product manufacturing processes
  • Coordinate Over the Counter (OTC) submissions and approvals to FDA.
  • Manage OTC mandated testing for active and inactive ingredients.
  • Responsible for maintaining documents and manage document databases.
  • Lead all validation activities in a hands-on approach with the validation activities.
  • Work on multiple validation projects simultaneously and coordinate test work.
  • Ensure all quarantine, sampling, and testing of raw materials and finished goods
  • Manage and communicate all third-party testing results in a timely manner
  • Conduct CAPAs and troubleshoot out of spec product and processing parameters
  • Write protocols for manufacturing, utilities, lab equipment and processes.
  • Oversee validation executions work according to protocol instructions and procedures.
  • Plan, coordinate and track the progress of validation projects.
  • Compile validation packages and assure all required documentation is accurate and complete.
  • Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure.

 

QUALIFICATIONS:

  • Bachelors in Biology, Chemistry, Engineering, or relates science, or equivalent experience
  • Equipment and facility validation: 3 years (Required)
  • Leadership/management: 3 years (Required)
  • cGMP environment: 5 years (Required)
  • Ability to support external and internal GMP audits
  • Strong leadership and organizational skills
  • Experience in products regulated as drugs and cosmetics in consumer goods or pharmaceutical products preferred
  • Strong communication skills (oral and written)
  • Collaboration skills

 

BENEFIT SUMMARY:

Medical, Dental, Vision, Company Paid LI, AD&D, Matching 401K, Employee Assistance Program, Paid Time off

 

 

PHM Brands is an equal opportunity employer and considers qualified applicants for employment without regard to sex, race, color, religion, ethnic or national origin, gender, sexual orientation, gender identity or expression, age, pregnancy, leave status, disability, veteran status, genetic information and/or any other characteristic or status protected by national, federal, state, or local law. ​

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