Job Description

QA Specialist
Job Number: 21-07003
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Specialist for our client in Warren, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Responsibilities:
  • Must have advanced knowledge and experience with cGMP manufacturing, quality, and compliance
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Must possess an independent mindset
  • Confident in making decisions for non-routine issues
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
  • Seeks management guidance on complex issues
  • Develops procedures
  • Proposes solutions for complex issues and works with management to resolve
  • Follows established procedures and performs work as assigned
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Is recognized Subject Matter Expert within the group
  • Provides guidance to other employees in interpretation of complex data
  • Understands continuous improvement and improves efficiency and productivity within the group or project
  • Builds relationships internally within and with cross functional teams
  • Review and approval of executed batch records
  • Issue production batch records and product labels to Operations
  • Responsible for disposition of incoming production materials
  • Responsible for release activities for site manufactured drug product
  • Provide oversight of QA shop floor program
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
  • Must be skilled in planning and organizing, decision-making, and building relationships
 
Qualifications:
  • Knowledge of US and global cGMP requirements
  • Excellent verbal and written communication skills
  • Contributes to goals within the work group
  • Able to recognize conflict and notify management with proposed recommendations for resolution
  • Able to prepare written communications and communicate problems to management with clarity and accuracy
  • Able to effectively multi-task
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision
  • Work is self-directed
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
  • Relevant college degree preferred, minimum of two years of experience in the pharmaceutical or related industry
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
Jane Bautista
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

 

Application Instructions

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