Job Description

Quality Assurance Specialist
Job Number: 21-01972
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance 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!
 
Position Overview:
  • Responsible for quality and disposition activities in accordance with Client policies, standards, procedures and Global cGMP.
  • Functional responsibilities include performing incoming material release and product release, as needed, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, On-Site coverage/participation in QA Shop Floor activities, and performing document issuance for manufacturing.
 
Responsibilities:
  • Participate in QA shop floor program.
  • Issue production batch records and product labels to Operations.
  • 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.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Able to effectively multi-task.
  • Revise department SOPs
  • Real time review and approval of executed batch records.
  • Responsible for Material Status Changes of production/drug product materials.
  • 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.
  • Is recognized Subject Matter Expert within the group.
  • Provides guidance to other employees in interpretation of complex data.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with cross-functional teams.
  • Contributes to goals within the work group.
  • Position handles hazardous materials
 
Qualifications:
  • Bachelors Degree Required, Science related degree preferred.
  • Minimum of four to five years of related Quality Assurance experience in the pharmaceutical industry required
  • Equivalent combination of education and experience acceptable.
  • Strong knowledge of cGMP principles required.
  • Strong cross-functional collaboration experience required.
  • Excellent Communications Skills are required.
  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
  • 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.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • 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.
 
Skills:
  • 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.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.
  • Labeling experience is highly preferred.
 
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:
John Bayog    
John.Bayog@eclaro.com
6466952925
John Bayog | 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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