Analytical Data Reviewer FL
PL Developments
Miami, FL
Analytical Data Reviewer FL
PL Developments
Miami, FL
- Full-Time
Job Description
Company Info
Job Description
JOB QUALIFICATIONS:
Company Description- Bachelor’s degree in chemistry or related field
- 5+ years Pharmaceutical analytical data review experience preferred
- Solid knowledge of cGMP, GLP, GDP concepts Federal Regulations
- Previous experience conducting Analytical data review
- Review of standard testing procedures (STM), general procedures, excipients COAs, packaging components COAs
- Operational understanding of laboratory equipment and pertinent software (Empower/LIMS)
- Critical thinking, problem solving, and analytical thinking applied to data and diverse situations
- Excellent interpersonal communication skills: verbal and written skills
- Able to work multiple priorities in parallel
- Computer proficiency: Word, Excel, and Power Point
Position Responsibilities:
- Final review of analytical data including, but not limited to raw materials, finish products, and stability data including method validation/ verifications
- Ensures that analytical data is in compliance with GMP, GLP, and GDP
- Manage routine minor corrections with the Lab Chemist
- Communicates any Out of Specification (OOS) or Out of Trend results (OOT) identified during data review to the QC Manager or Quality Director
- Informs the QC Manager or Quality Director of any critical data integrity issues or data irregularity
- Support other tasks that might be oriented by the QC Manger or Quality Director
Physical Requirements:
- Adhere to all safety policies; includes wearing personal protective equipment when required
- Ability to work standing/walking 50% of the time
- Ability to occasionally: lift 10-50lbs, carry 10-50lbs and to stand, bend and stoop
PL Developments is an over-the-counter pharmaceutical manufacturing and packaging company, headquartered in New York. We have an excellent work environment, truly invest in our people, and believe in great work/life balance. We offer a comprehensive benefits package.
PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
PLD participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Create or sign into a ZipRecruiter account, and then apply on the company site¹
You Already Have an Account
We're sending an email you can use to verify and access your account.
If you know your password, you can go to the sign in page.
