Search Jobs
QC Data Reviewer
Job Description
Job Description The Role
In this role, you will support QC Labs with review of test records.
Heres What Youll Do
- Review executed QC test records for product release and environmental monitoring.
- Additional duties may be assigned
Heres What Youll Need (Minimum Qualifications)
- BA or BS degree in Biology, Microbiology or similar field
- 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
- Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
- Previous experience managing quality records such as change controls, deviations, and lab investigations
Heres What Youll Bring to the Table (Preferred Qualifications)
- In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
- Experience with rapid microbiological methods
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
Sunday-Wednesday Second Shift
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Norwood, MA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.