Primary Talent Pa rtners has a contract opening for a QA Lead Technical Operations with a client of ours in Devens, MA. This is a 6-month contract opening with the potential for extension.
Pay Range: $62- $65- W2, no PTO or Benefits included
Job Summary:

• QA Lead Technical Operations
• 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 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 approve 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 the Reporting Manager.
• This position will sometimes interact with these departments:

1. Quality Control
2. Manufacturing Operations
3. Manufacturing Engineering
4. Manufacturing Science and Technology (MS&T)
5. Validation
6. Site Engineering
7. 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, and 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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