QA Operations Lead

Primary Talent Partners has a 6-month contract opening for a QA Lead Technical Operations Specialist with a client of ours in Devens, MA. This role is 100% onsite. 

Duration: 6-month W2 contract, no PTO or benefits
Pay: $61 - $66.39
Job Title: QA Lead Technical Operations, Projects
Location: Devens, MA
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
Contractor must be able to come onsite Monday through Friday - 1st shift

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
  

This position may interact with:

• Reporting Manager
• 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 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.
  

Contractor must be able to come onsite Monday through Friday - 1st shift

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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