Lead QA Operations Tech
BMS ID # 57790-1
Devens, MA- ON SITE
10 month W2 contract (with potential to extend or transition to perm)
Pay rate: $58-66/hour - Depending on Education and Experience
Summary:
Work Schedule: Mon - Fri, First shift (8:30AM - 5PM)
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

Skills or Requirements:

• 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

Education/Experience:

• 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.

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.