DUTIES & RESPONSIBILITIES:
The QC Lab Manager manages and coordinates cGMP laboratory activities for an aseptic filling CMO; supporting Medical Device and Pharmaceutical product platforms, including personnel management, project management, analytical method development, and validation. The QC Lab Manager is responsible for the development, optimization, trouble-shooting and technical transfer of routine and non-routine chemical and microbial assays and formulation transfers, and will support process qualification. The QC Lab Manager works independently and collectively as part of an integrated team environment with extensive interactions with Manufacturing, Maintenance, QA, and Administrative departments. The QC Lab Manager is responsible for OOS investigations, ENCAR Reports, and product MRB disposition in coordination with the QRT Team. The QC Lab Manager will report directly to the General Manager.
Job Roles required of the position:
· Manager: Maintains QC Lab service by enforcing organization standards, and providing guidance to subordinates. Actively supports the QC Lab and business requirements of the EMS and QC Lab Systems.
· Microbiologist, Chemist, Lab Tech, QC Line Testing, and Clean/Sanitization of Lab: Provides oversight to direct reports performing these job roles and assumes accountability for the work performed. Actively reviews reports and documents for compliance to requirements.
· Facility Maintenance: Provides oversight to direct reports performing this job role in support of laboratory equipment and assumes accountability for the work performed. Actively review reports and documents for compliance to requirements. Maintains the calibration program and tracks calibration for the site.
· Validation: Represents QC Lab for engineering and validation programs by reviewing and approving validation documents, supporting engineering and validation efforts with personnel resources. Write new procedures to support new systems or new product realization projects.
· Purchasing: Uses the purchasing system to procure laboratory and validation supplies.
· DCR System: Directly manages the DCR System to change or add new document requirements. Coaches personnel assigned as a DCR Coordinator in the writing and revision of documents.
· CIMP System: Supports the continuous improvement and Kaisen events and projects related to the lab.
· NCR System: Provides investigation and root-cause analysis for lab related NCRs.
· Training: Provides training to direct reports to support continued competency. Monitors employee progress and competency to promote continued employee growth.
Plastikon Healthcare LLC (Lawrence, Kansas) is a specialty pharmaceutical company focusing on contract manufacturing of products for medical device, and pharmaceutical industries. The Lawrence facility provides turnkey solutions for final product presentations; from formulation through final packaging. Our core competencies include Blow-Fill-Seal (BFS), aseptic traditional filling, terminal sterilization, injection molding, formulation, in-process & release testing, and process validation. Plastikon Healthcare offers competitive salaries; health benefits to include medical, dental, vision, life insurance, supplemental life, EAP, PTO, Holidays and 401(k). Must satisfactorily pass a background check and pre-placement drug test. Plastikon Healthcare is an Equal Employment Opportunity/Affirmative Action Employer and maintains a Drug-Free Workplace. EOE-M/F/Vet/Disability