Top 1 quality control associate Jobs in seminole, fl

Stability Coordinator/Associate QC Chemist
Eagle Labs, Inc —Seminole, FL
- $45,000 - $65,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
14d

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Stability Coordinator/Associate QC Chemist

Eagle Labs, Inc -
Seminole, FL

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Job Details

Full-time
$45,000 - $65,000 a year
14 days ago

Qualifications

Statistics
Stability testing
Microsoft Excel
Content creation for technical audiences
Microsoft Outlook
Stability studies in drug product development
Technical documentation
Technical writing within manufacturing
GMP
Trend analysis
Data integrity and documentation
ICH guidelines
Bachelor's degree
Data management
Desktop applications
Managing projects
Regulatory compliance analysis
Engineering environmental testing
Document management systems
FDA regulations

Full Job Description

Overview:

The Stability Coordinator/Associate Chemist is responsible for the administration of the stability program which includes, scheduling of the stability sample pull points, pulling samples, scheduling and sending out samples for testing, monitoring environmental stability storage chambers and setting the samples down on stability according to the relevant procedures, supporting the site's Stability Program coordinating sample management activities, and ensuring compliance with cGMP, SOPs, and ICH guidelines.

Additional responsibilities are to perform testing, review, approve data, ensure cGMP/GLP practices are following regulatory requirements, equipment management/maintenance, lead investigations, deviations, out-of-specifications (OOS). Collaborate with Quality control manager, director and other departments.

Requirements:

The successful candidate must be able to work independently on multiple projects and meet established timelines

Applicant must have a bachelor's degree with at least 3-5 years of experience
Stability program experience required
Relevant Quality experience, preferably in the bio/pharmaceutical/supplemental and/or nutraceutical industry
Knowledge of stability and cGMPs
An understanding of stability testing, FDA, ICH, and applicable stability regulations is required
Knowledge in statistical concepts for appropriate interpretation of stability data (e.g. trending analysis)
Strong technical writing skills
Proficiency with computer systems (Microsoft Office applications)
Experience with document management systems
Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential)
Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office

Responsibilities:

In this role, you will play a crucial role in our quality control process, providing support for stability studies and ensuring compliance with regulatory guidelines

Conducting and overseeing stability studies to ensure product quality and compliance with regulatory guidelines
Providing support for product testing and analysis, including sample preparation, data analysis, and report writing
Maintaining and updating quality control documentation and record
Identifying and resolving quality control issues and deviations in a timely manner
Collaborating with cross-functional teams to ensure timely completion of projects and adherence to quality standards
Communicating with external vendors and suppliers to ensure timely delivery and quality of materials and with outside contract laboratories on testing.

Schedule testing and sending out samples to contract laboratories and maintaining communication and follow ups on status and results

Participating in internal and external audits and inspections

Staying up to date with industry regulations and guidelines related to quality control

Participating in continuous improvement initiatives to enhance quality control processes and procedures

Prioritizing and managing multiple tasks and projects to meet deadlines

Ensuring compliance with company policies and procedures

Enter studies into the computerized stability management system in accordance with SOPs.
Compile, interpret, and evaluate data and identify impacts related to deviations, OOS/OOT results, or excursions.
Maintain inventory, coordinate final sample destruction, and reconcile stability materials.
Prepare samples for shipment, complete related documentation, and perform peer reviews.
Ensure compliance with cGMP, quality policies, and guidelines.
Review internally and externally produced laboratory data for finished products and raw materials.
All other duties as assigned.

Education:

Bachelor’s degree in related scientific discipline and 4-5 years of experience with documentation systems and cGMP-compliant environments required.
Experience with sample tracking is preferred.
Strong organizational, technical writing, and communication skills.
Knowledge of stability program expectations, sample handling, data integrity, and QMS principles.
Proficiency with Microsoft Outlook, Excel, and Word.

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Stability Coordinator/Associate QC Chemist

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