Job Description

Reference # : 17-07724Title : QA Associate
Location : Pennington, NJ
Experience Level : Start Date / End Date : 08/23/2017 / 02/22/2018
Assignment Detail
Industry:Biotech/Pharma
Description
QA Associate

Work for a global healthcare leader. Eclaro is looking for a QA Associate for our client in Pennington, 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:
  • Review executed batch records in-process and release tests and associated supporting documentation from clinical production areas
  • Coordinate record correction activities related to batch release, data review, trending and release data reconciliation against Certificate of Analysis, specification, and LIMS
  • Assist in preparation of lot release documentation for accuracy, GMP compliance, and validity
  • Support development of quality Standard Operating Procedures, their revision, and perform additional QA related activities as assigned
  • Work closely with other QA associates to ensure that all compliance requirements are met in manufacturing, testing, completion of environmental monitoring data reviews, closure of deviations and change controls, and availability of supporting documentation to ensure timely disposition of drug substance batches within the required cycle time
  • Support team members with facility routine and pre-operational walkthroughs, equipment and room release functions, and participate in internal audits as necessary to ensure compliance in GMP areas
  • Collect metrics related to batch release functions and ensure meeting of the required drug substance release cycle time
  • Work closely with cross-functional groups in resolving any discrepancies observed during the GMP documentation review and report any non-conformances in the executed batch records or reviewed testing so they are addressed appropriately
  • Support investigations associated with manufacturing operations and analytical testing activities, and may be rotated on the production floor to provide timely quality support and coaching to production operators during critical operations

EDUCATION, EXPERIENCE, AND SKILLS REQUIRED:
  • B.S. Degree in Chemistry, Microbiology or other associated biological science
  • 4-6 years of related experience in the pharmaceutical or biologics industry, with at least 2 years focused in a quality assurance or regulatory compliance area
  • Knowledge of US, EU, and cGMP regulations and guidance
  • Knowledge and general understanding of regulatory requirements pertaining to biopharmaceutical manufacturing is preferred
  • Ability to communicate clearly and succinctly, both verbally and in writing
  • Ability to work independently under tight timelines and make sound judgments while ensuring compliance with regulations and approved procedures
  • Ability to effectively interact with all contacts, and work in a team-based environment and interact well with other employees at various levels
  • Flexibility and capability of handling several high priority items simultaneously on an ongoing basis

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • TransitChek Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying? Contact Elland Bondoc at (201) 283-9624 or send your resume to Elland.Bondoc@eclaro.com now.
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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