QC Analytical Manager — GMP Leadership & Validation

Goodwin-Biotechnolog

Plantation (FL)

On-site

USD 110,000 - 170,000

Full time

14 days+

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Goodwin-Biotechnolog in Plantation, FL seeks a Lead, Quality Control Analytical to manage and supervise the QC Analytical team with a strong technical and scientific background in the pharmaceutical industry. The role emphasizes ensuring compliance with quality standards and regulatory requirements, and overseeing analytical method transfer from Process Development.

The candidate will lead investigations for OOS/ABT/OOT, drive corrective actions, and ensure timely execution of QA testing and

Qualifications

Must have strong problem-solving abilities and sound judgment under challenging circumstances.
Excellent written and verbal communication skills; promote intra- and inter-department cooperation.
Knowledge of GMP, ICH, and compendial requirements and their application.
Strong leadership, organization, and attention to detail.

Responsibilities

Provide leadership and strategic direction for the Department.
Ensure Analytical Services comply with GMP/GLP standards and guidelines.
Support and lead design, development, and qualification/validation of analytical methods.
Coordinate timely transfer of methods to QC Group from Process Development.
Ensure testing of products complies with regulatory standards and is completed on schedule.
Develop and manage stability program schedules and QC lab schedules.
Review and supervise generation of reports and SOPs.