Posted on: January 16, 2022
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,
- Review and approve Quality system and batch related
documentation (e.g., cGMP procedures, batch records, solution
records, QC testing, Certificates of Analysis, protocols, and
- Review and Approve Reports (validation, stability studies,
- 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
- Provide mentoring and training to staff that are new to
regulatory requirements and to facilitate their use of established
- Collaborates with internal and external stakeholders to ensure
that regulatory agency quality assurance requirements are met.
- Participate in Regulatory inspection and other audits, as
- 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 &
- 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
- 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
- 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
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