Quality Assurance Specialist III

Full time temp to permanent position, Hybrid onsite in Cambridge MA 3 days per week

Position Overview:
The Quality Assurance Specialist III of Clinical and Commercial FG Quality Operations is responsible for providing support to GMP aspects of Clinical and commercial finished goods assembly, packaging, and labeling with a primary focus on Clinical. This role will work cooperatively with their counterparts throughout Quality Operations to provide quality oversight and support to ensure clinical and commercial lifecycle activities meet GMP regulatory requirements and guidelines. This position reports to the Senior Manager - FG Quality Operations. Minimum BS degree in life sciences, engineering, or related field.

Required Skills:

• PROCEDURE WRITING
• CAPA
• CHANGE CONTROL
• BATCH RECORD REVIEW
• SUPPLIER MANAGEMENT

Key Responsibilities

• Execute quality oversight of manufacturing clinical and US commercial finished goods assembly/packaging/labeling up through lot disposition to include review and approval of Deviations, Change Controls, CAPAs.
• Provide quality oversight of our external clinical and US commercial finished goods manufacturing network quality management systems, ensuring compliance with regulations in all relevant markets.
• Perform data migration activities in support Product Specification File expansion.
• Three (3) to five (5) years of relevant QA work experience in a regulated industry Experience of firsthand GMP management is preferred and will include exposure to FDA or other authorities of similar standing.
• Operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .

Advantage Technical 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 Technical 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.