QA LEAD - TECHNICAL OPERATIONS DEVENS, MA Hybrid role- 50% onsite. Some activities can be done remote and other activities must be done onsite. Contractor must be able to come onsite when needed. Work Schedule- Monday through Friday - 1st shift.
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.
12 years of experience in a GMP, GCP, or GXP with at least 10 years focused on product quality, preferred Active member of ASQ or ISPE.
Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
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, 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.
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.
This position will regularly interact with:
Reporting Senior Manager
Sometimes will interact with departments listed below:
Manufacturing Science and Technology (MS&T).
This 7+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com
ALPHA' S REQUIREMENT #23-00134
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE