QA Deviation Reviewer

Company : Medvacon Life Sciences

Job Type : Full Time

Baltimore, Md

Number of Applicants

000+

Let AI Supercharge Your Job Hunt!

JobCopilot scans 500,000+ company career sites daily to find jobs for you

Never miss an opportunity Save hours by auto-filling applications forms Land more interviews with tailored applications

Activate JobCopilot

Job Description - QA Deviation Reviewer

The QA Deviation Reviewer role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations, in accordance with company policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.
Responsibilities:

Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
Review all data in accordance with applicable procedures and cGMP requirements.
Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
Support document revision, project, CAPA, and investigation/deviation related tasks.
Perform assigned tasks within a CAPA, deviation, or project.
Participate in projects and continuous improvement efforts.
Perform other tasks as assigned.
Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.
Ability to adapt to multiple changing priorities.

Knowledge & Skills:

Must have knowledge and experience with US and global cGMP manufacturing, Quality, and Compliance.
Understanding and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
Supports quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
Must provide guidance to other employees in the interpretation of technical/scientific issues.
Must possess an independent mindset and tenacity.

Basic Requirements:

Bachelor's degree required, preferably in science-based field.
1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company with CAR T or Biologics experience.
1-2 years of minimum within a manufacturing GMP environment.
Good technical writing skill-set.

Preferred Requirements:

Advanced degree, in a science area.
Knowledge of LIMS and laboratory data analysis systems.
Support in Health Authority Inspections.

Original job QA Deviation Reviewer posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.

Auto-Apply to Similar Jobs

Share Job

Get your Resume Reviewed for Free

Automate Job Applications for Similar Jobs

Auto-Apply to QA Deviation Reviewer Jobs with your AI JobCopilot

Auto-Apply with AI

Similar QA Deviation Reviewer Jobs in the US

Get your Resume Reviewed for Free

Email address

Why are you reporting this job?

I think it’s a discriminatory or offensive

I think it’s fraudulent or a scam

I think it’s trying to sell something unrelated to the job / it’s asking for money

I think it contains incorrect or broken information

Other

All Job Ads are subject to GrabJobs’s Terms of Service. We allow users to flag postings that may be in violation of those terms. Job Ads may also be flagged by GrabJobs moderation team. However, no moderation system is perfect, and flagging a posting does not ensure that it will be removed.

Setup your job alert:

Frequency

By activating job alerts, I agree to GrabJobs Terms & Privacy Policy. I can unsubscribe to job alerts anytime. Skip

QA Deviation Reviewer

Job Description - QA Deviation Reviewer

Similar QA Deviation Reviewer Jobs in the US

Mobile Apps