Quality Assurance Specialists/Managers

Domain: HealthTech, HighTech
Career Path: RTech
Type: Full Time preferred

Seniority: Mid senior level
Location: Cambridge, MA

Skills

Common Skills.

Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products

  • Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
  • Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
  • Solid understanding of CMC requirements for INDs, BLAs, and other regulatory filings
  • Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.
  • Experience in participating in deviation investigations, determining root cause, and developing corrective action plans

Education

BSEE, BSCS, BSME

BS,MS, PHD Biostatistics, Life Sciences, Engineering, Chemistry, Biology

Quality Assurance

Experience

Sr. Quality Assurance Specialists/Managers for a position based at their Cambridge, MA site. The individual in this role will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development. The individual will primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

Description

Arrayo is seeking a Sr. Quality Assurance Specialists/Managers for a position based at their Cambridge, MA site. The individual in this role will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development. The individual will primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

We are looking to hire the following skills:

GMP documentation: Author & Review SOPs, protocols and technical reports

Validation: Develop validation plans for GMP systems; Author, review and approve validation protocols; Execute validation protocols; Writing validation reports

Quality Trainings: Develop and implement GMP training programs

Investigations / CAPAs: Execute quality investigations and CAPAs and review associated protocols

QMS: Create and maintain Quality Management Systems (internal & supplier)

Supply Chain: Execute and review supplier audits; Ensure continuous supply

Management: Quality project & process Management

Operational Quality: Batch records reviews

 

 

Essential Duties & Responsibilities

GMP documentation: Author & Review SOPs, protocols and technical reports

Validation: Develop validation plans for GMP systems; Author, review and approve validation protocols; Execute validation protocols; Writing validation reports

Quality Trainings: Develop and implement GMP training programs

Investigations / CAPAs: Execute quality investigations and CAPAs and review associated protocols

QMS: Create and maintain Quality Management Systems (internal & supplier)

Supply Chain: Execute and review supplier audits; Ensure continuous supply

Management: Quality project & process Management

Operational Quality: Batch records reviews

Quality Assurance Specialists/Managers

Submit CV now.

Arrayo is an Equal Employment Opportunity employer and as such does not discriminate against any applicant for employment or employee on the basis of race, color, religious creed, gender, age, marital status, sexual orientation, national origin, disability, veteran status or any other classification protected by applicable discrimination laws.