QA Manager

ALS Environmental$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline (preferably chemistry, microbiology, or biology)
  • 7+ years of experience in a commercial laboratory
  • 5+ years in a quality function, ideally in a TNI or ISO 17025 accredited environment
  • 2+ years of leadership or management experience preferred
  • Strong organizational, communication, and leadership skills

Responsibilities

  • Manage and improve laboratory quality systems
  • Ensure compliance with regulatory requirements and ALS standards
  • Plan and oversee annual internal audits
  • Maintain active accreditation status for relevant programs
  • Oversee site document control including the Quality Manual
  • Manage annual proficiency testing program and resolve failures
  • Schedule and participate in external audits and assessments

Benefits

  • Professional development opportunities
  • Supportive work environment with a focus on quality
  • Opportunity for collaboration across teams
  • Access to continuous improvement tools
  • Potential for career advancement in quality management
Full Job Description
Primary Objective:

The Quality Assurance Manager is responsible for executing, maintaining, and continuously improving the laboratory's quality management system.

Primary Responsibilities:

The Quality Assurance Manager, USA Environmental has the following duties:
  • Direct management and improvement of the laboratory quality systems.
  • Ensuring the quality management systems remain compliant to all applicable regulatory requirement and ALS standardization improvements.
  • Planning and oversight of the annual internal audit schedule.
  • Oversight of the maintenance of active accreditation status for all applicable programs.
  • Maintenance of site document and the document control system including the site Quality Manual and other site procedures.
  • Planning and oversight of the annual proficiency testing (PT) program including the timely resolution of any failures.
  • Scheduling and participating in external audits and assessments as required by regulatory bodies and/or Clients.
  • Ensure that good, easily retrievable records are maintained of the training, assessment and audits.
  • Oversight of the timely resolution of nonconformances, corrective actions and client complaints.
  • Develop and maintain the approved vendor list.
  • Manage site quality personnel and participate in performance evaluations.
  • Other duties as assigned.


Core Competencies:
  • Demonstrated knowledge of the requirements of applicable national and international standards and guidelines
  • Knowledge of site/state specific regulatory requirements will be an asset.
  • Must have strong organizational, communication and leadership skills, and be able to work independently and as part of a team.
  • Able to establish and maintain a positive rapport with internal and external stakeholders.
  • Demonstrated ability to problem solve and pay close attention to detail.
  • Excellent verbal communication skills.
  • Must have a working knowledge of Microsoft Office applications.
  • Proficient written communication skills.
  • Excellent organizational skills and attention to detail.
  • Proficient computer skills, specifically Microsoft Office.
  • Problem solving skills.
  • Promotes a productive and professional work environment.
  • Must be able to work independently with minimal supervision.
  • Adheres to safety policies and practices.

Position Requirements:
  • Bachelor's degree in a scientific discipline (preferably chemistry, microbiology, or biology).
  • Minimum of seven (7) years working experience in a commercial laboratory
  • Minimum of five (5) years of experience in a quality function, preferably in a TNI, ISO 17025, or similar accredited environment.
  • Minimum of two (2) years of leadership or management experience preferred.

Other Requirements:
  • Perform other duties as assigned by the National Quality, Technical & Innovation Director, Regional Quality Manager, or Laboratory Director.
  • Must be able to stand, bend, push, pull, stoop and crouch up to 50% of the time while performing the duties of this position.
  • Must be able to work on computer while sitting for up to 8 hours per day.
  • Manual dexterity to perform intricate and/or repetitive tasks.
  • Wear personal protective equipment (PPE) such as safety glasses, gloves, etc. when required.
  • Ability to travel as needed.


NOTE: This job description is not intended to be all-inclusive. Employees may be required to perform other job-related duties as assigned to meet the ongoing needs of the organization.

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