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Sr. Quality Assurance Associate in Cambridge, MA at APEX Systems

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job #:  939483

Senior Quality Assurance Specialist, 939483
 

Job Scope & Purpose:

Our Cambridge based client is looking to add a talented QA Specialist to their ranks. Key to this role is the ability to work in a fast-paced, collaborative environment, while meeting timeline deliverables, is required.  Competencies in the following areas: attention to communication; oral communication skills; technical writing skills; building collaborative relationships; thoroughness; ability to make decisions in a timely manner; adaptable to changes.

Primary Job Responsibilities:

•  Author and perform a cross-functional review of SOPs for compliance and best-practice

•  Participate in CAPA, deviation, risk assessment, and technical transfer teams

•  Support and participate in the document control program

•  Oversight of the change management program

•  Participate in internal audit activities

•  Conduct supplier qualifications

•  Support materials management in receipt and release of raw materials

•  Issue, review and release cellular product batch records

•  Assist with staff training and documentation

 Primary J

Job Requirements

•    Bachelor’s degree in the life sciences (cell biology is desirable)

•    At least 4+ years’ experience in an FDA-regulated environment with GLP and GMP knowledge

•    Knowledge of applicable regulatory requirements

•    Strong documentation and coordination practices

•    Strong interpersonal and communication skills

•    Experience in cellular therapy manufacturing is a plus 

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

kschott@stratacuity.com

kkerouac@stratacuity.com

Code:RegQA

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178