Job Description

QA Shop Floor Specialist
Job Number: 21-16485
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Shop Floor Specialist for our client in Summit, 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 activities supporting Manufacturing Operations in accordance with client’s policies, standards, procedures, and Global cGMP.
  • Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

Responsibilities:
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Work is self-directed.
  • 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.
  • 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.
  • 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.
  • Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing and other departments to effectively accomplish responsibilities make improvements and resolve issues.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.
  • Issue production batch records and product labels to Operations.


Qualifications:
  • Bachelors degree with 4+ years of relevant work experience, or an equivalent combination of education and experience
  • Aseptic experience preferred.

Required Skills:
  • Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
  • 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.
  • 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.
  • 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.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.

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: 
Chris Imbien
Chris.Imbien@eclaro.com
(843) 872-9257
 
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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