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Quality Specialist

Company: Advantage Resourcing
Location: Cambridge
Posted on: January 13, 2021

Job Description:

Quality Specialist We are currently seeking a seasoned Quality Specialist for a 3+ month contractual opportunity (excellent opportunity for extensions) with our client in Cambridge, MA. The qualified candidate will be responsible for evaluating, reviewing, and approving CAPAs or Change Control and you will also support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.Responsibilities:* Conduct QA assessments of product specific change controls, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker* Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations* Work with functional groups across the site to review and approve quality and technical documentation including: CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation.* Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities* May perform archiving duties in support of QA Document Control* Will perform data migration from paper systems to new electronic data systems. Education / Required Skills:* Minimum of BA/BS Degree * Preferred experience working in 2+ functional areas* Experience in cGMP Quality Control operations in a fast-paced production environment* Demonstrated ability collaborate across the business.* Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.* Demonstrated ability to present ideas persuasively and negotiate effectively* Excellent written and oral communication skills both internal and external.About Advantage ResourcingAdvantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

Keywords: Advantage Resourcing, Cambridge , Quality Specialist, Other , Cambridge, Massachusetts

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