QA Specialist

Company: Aerotek
Location: Medford
Posted on: January 16, 2022

Job Description:

Hi Everyone! Please see below for a great opportunity for a QA Specialist in Medford, MA! This company is growing at a rapid rate and isseeking a highly motivated and collaborative individual to join the team.Description:Reporting directly to the QA Sr. Quality Systems Manager, the individual will be a key contributing member of our Life Science Team. The candidate will assist with creation of QMS systems and governing SOPs as well as the review of executed documents (i.e., batch records, validation protocols, etc.). Additional responsibilities will relate to activities supporting the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will have experience with document control and quality systems in a regulated industry setting (e.g., FDA GLP / cGMP). Key Position Responsibilities

• Create and implement standard operating procedures, protocols, reports etc.
• Review and approve Quality system and batch related documentation (e.g., cGMP procedures, batch records, solution records, QC testing, Certificates of Analysis, protocols, and reports, etc.)
• Review and Approve Reports (validation, stability studies, etc.)
• Ability to initiate and support the management of CAPAs, deviations, investigations etc. as well as monitor completion of such quality compliance activities.
• Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, and Quality Control departments.
• Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems.
• Collaborates with internal and external stakeholders to ensure that regulatory agency quality assurance requirements are met.
• Participate in Regulatory inspection and other audits, as required.
• Oversight of equipment status from calibration, maintenance, validation, change control, and product changeover, etc.
• Identify potential compliance issues and opportunities for improvement to the overall Quality System. Provide resolution of both technical and compliance issues or gaps.
• Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation).
• Perform duties regarding special projects, as assigned by QA Management.Skills:ICH Compliance, ICH GMP, ICH, FDA, FDA Compliance, complaint handling, SOP, SOP writing, batch record, batch record reviewAdditional Skills & Qualifications:Qualifications:
  • Bachelors degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 3+ years combined of experience in quality system management.
  • Non-degreed candidates with 6+ years combined of relevant GLP/GMP quality systems experience will be considered.
  • Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
  • Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).
  • General understanding of Quality concepts/requirements and be able to practice and implement them, as well as GMP Manufacturing processes and drug products.
  • Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged environment.
  • Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
  • Experience creating /reviewing / approving documentation such as Standard Operating Procedures (SOPs), Work instructions, Batch Records, protocols, etc.
  • Experience with performing audits, and participating in audits to include regulatory agency inspections.
  • Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
  • Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).Please apply to this posting or reach out directly to!About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Medford , QA Specialist, Other , Medford, Massachusetts