What are the responsibilities and job description for the QA Lead Technical Operations position at Eclaro?
Job Number: 24-01813
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Lead Technical Operations 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:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | 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.
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Lead Technical Operations 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:
- 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
- Digital Plant
- Comfortable working in an FDA regulated environment.
- Provides Quality Assurance (QA) support to Client’s Site and Reporting Manager 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 WWQC 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.
- 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, TrackWise, 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.
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | 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.
