Job Description :
QA Lead Technical Operations, Projects
Onsite, Devens location
Work Schedule : Mon - Fri, First shift (8 : 30AM - 5PM)
Job Description / Responsibilities :
- Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and
pproval of Investigations and Corrective Actions.
Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectationsReviews and approves Quality, Quality Control, Validation and Automation related documentsReview and approves Standard Operating Procedures (SOPs).Review and approval of Validation related documentation such as risk assessments, protocols and test scripts andsummary reports.
Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meetexternal regulatory and internal WWQC guidelines and requirements.
Ability to coach across different departments within the subject matter of Investigations, CAPAs, general riskssessments and Validation.
Ability to self-manage and prioritize work across multiple competing deliverables, in a remote workingenvironment
Able to interpret complicated data and make sound decisions, IndependentlyThis 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
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, GCP, or GXP with at least 8 years focused on productquality. Preferred Active member of ASQ or ISPE.
Prior experience of QC equipment Qualification and some project management experienceKnowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing ishighly 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 electronicor paper based batch records desirable.
Excellent Technical writing and oral communication skills are required.Background in problem solvingKnowledge of Data integrity principlesProven attention to detailsComfortable working in an FDA regulated environment.Contractor must be able to come onsite Monday through Friday - 1st shift
