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1+ months

QA Lead Technical Operations

Kelly Services
Devens, MA 01434
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **QA Lead Technical Operations** at a prestigious Fortune 500 company working in **Devens, MA.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: QA Lead Technical Operations**


**Pay: $66.39 per hour**


**Roles and 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


**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.

Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.

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.


Notes: Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.

Hybrid role- some activities can be done remote and other activities must be done onsite

contractor must be able to come onsite when needed

Monday through Friday - 1st shift


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-03-15 Expires: 2021-04-29

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QA Lead Technical Operations

Kelly Services
Devens, MA 01434

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