Job Description

Senior Quality Specialist
Job Number: 20-08038
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Payroll Business Analyst for our client in Devens, MA.
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:
  • Performs and troubleshoots routine and advanced processing and data review of raw materials, in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant environment.
  • Executes and improves procedures owned by the Sample Management functional area.
  • Assignments are made in the LMS, by the hiring manager, based on applicable curricula map(s).
  • Author revisions to SOPs for managerial review and approval and drafts new documentation where appropriate
  • May author protocols and/or reports as required.
  • Trained on multiple procedures/processes, and provides support to a wider spectrum of Sample Management responsibilities.
  • Executes troubleshooting techniques independently, and helps support junior analysts.
  • SME in multiple aspects of sample management.
  • Trainer for multiple Sample Management processes: responsible for training less experienced analysts.
  • Primary resource for qualification and validation testing support.
  • Leads investigations for sub-team.
  • May be assigned as team leader overseeing day to day execution of a shift of junior analysts
  • Should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions.
  • Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments.
  • May be expected to supervise daily operations of a team, without official people management responsibilities.
  • Will be expected to participate in the training of less experienced staff as well as assisting less experienced staff in normal operational tasks.
  • Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QC and QSS, in order to exchange information regarding sample management as it relates to meeting department goals and objectives
  • Daily contact with her/his supervisory staff for work assignments.
  • Routine contact with supervisor for coaching and general performance management discussions.
  • Occasional contact with other line management staff relating to specific project responsibilities may be expected.
  • May represent QC Sub-team or functional area in cross functional teams or projects.
  • Frequent contact with Manufacturing and Stability organizations for troubleshooting and forecasting/planning
  • Cross-site/vendor communications as needed for strategic purposes
  • May be required to coordinate with site stakeholders for troubleshooting purposes
  • Quality Assurance as necessary
Required Qualifications:
  • Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, supply chain, a related discipline, or the equivalent in related experience.
  • A minimum of 6 years of experience in cGMP Biologics QC laboratory or related cGLP or cGMP lab.
  • Proficiency (or mastery) of one or more of the methodologies within the QC sub-team.
  • Attention to detail and demonstrated organizational skills.
  • Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
  • Proficiency in applying cGMP regulations and compendial testing required.
  • Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
  • Demonstrates leadership, and independent problem solving and analytical thinking skills.
  • Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar.
  • Primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
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:
Jay Lucas
Jay Lucas | 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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