QA Lead Technical Operations

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This range is provided by ECLARO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$66.00/hr - $70.00/hr

Job Number: 25-04827

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QA Lead Technical Operations 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 :

• This position will regularly interact with:
  Reporting Manager.
• Sometimes will interact with departments listed below:
  Quality Control, Manufacturing Operations, Manufacturing Engineering, Manufacturing Science and Technology (MS&T), Validation, Site Engineering, and Digital Plant.

• Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations.
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal client’s guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment.
• Able to interpret complicated data and make sound decisions, Independently.

• Knowledge of science generally attained through studies resulting in a
  
  B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality.
• Preferred Active member of ASQ or ISPE.
• Prior experience of QC equipment Qualification and some project management experience
• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, Track Wise, Veeva Vault and electronic or paper-based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving.
• Knowledge of Data integrity principles.
• Proven attention to details.
• Comfortable working in an FDA regulated environment.
• Quality Control Equipment experience.
• Technical Writer.
• Investigations/Deviation experience.

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO