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QC Supervisor

Company: Aerotek
Location: Medford
Posted on: January 9, 2022

Job Description:

Hi Everyone! Please see below for an awesome opportunity for a QC Supervisor in Medford, MA! This company is growing at a rapid rate and is seeking an individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. They will be reporting directly to the QC Laboratory Sr. Manager, the individual will be a key contributing member of our Life Science Team.Description:The team is looking for a high-performing, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The position will assist in running a Quality Control (QC) Laboratory providing support to the advancement of mRNA based human vaccines and other RNA based therapeutics. The ideal candidate will provide technical and supervisory leadership to QC analysts.Key Position ResponsibilitiesThis position is responsible for providing compliance and technical support to QC analysts. As product development occurs, the QC Supervisor will be responsible for the following activities:oReview and evaluate in-process, release, and stability data.oRepresent functional area in meetings and compliance activities.oEnsure timely escalation of critical issues.oCoordinate daily schedules and assignments as necessary.oInitiate / lead laboratory deviations, investigations, OOS and provide support/ mentoring to QC analysts.oWork closely with external department to execute equipment qualifications / validations.oSupport operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training).oWork closely with analytical development team to support phase-appropriate test method qualifications / validations as needed.oParticipate in providing the necessary information for regulatory filings and inspections.oParticipate in audits (internal and external) and in remedial actions for any non-compliance.oCollaborates with internal and external stakeholders and partners to ensure that regulatory agency quality assurance requirements are met. May assist with auditing Contract Research Organizations as well as assist with hosting regulatory agency (e.g., FDA) inspections. oOther duties as needed.Skills:mrna, ICH, biologics, LIMS, method validationAdditional Skills & Qualifications:Position RequirementsBachelors degree with 5 7+ years in a biotechnology discipline or MS 4+ years of experience in a cGMP/GxP environment is preferred.Preferable hands-on experience working with mRNA.Superb organizational, analytical, and communications skills and do-what-it-takes attitude.Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.Knowledge of applicable GMP regulations, ICH & FDA guidelines, USP, and other applicable regulatory guidance's (US and EU).Ability to succeed in a team-oriented environment under very dynamic conditions. Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.Previous experience with LIMS preferred along with advanced skills with MS Office applications and Adobe Acrobat.Experience Level:Expert LevelPlease 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 , QC Supervisor, Other , Medford, Massachusetts

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