Need Senior Manufacturing Quality Engineer

Onsite, Devens location
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)

Top Skills/Must Haves:

1. Quality Control Equipment experience preferred
2. Technical Writer
3. Investigations/Deviation experience preferred

Job Description/ Responsibilities:

• 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 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, in a remote working

environment

• Able to interpret complicated data and make sound decisions, Independently

Education, Experience, and Qualifications:

• 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, Google Cloud Platform, 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
• Comfortable working in an FDA regulated environment.