QC Laboratory Supervisor - 2nd Shift

Category: 
Manufacturing & Engineering
Job Location: 
Sugar Land, TX

Are you highly motivated and ready for a change and want to join a growing company in a fast-paced environment? Are you looking for a new challenge in your career? Our client, a leading provider of high quality Compounding Sterile Preparations (CSP's), is in need of an impact employee. If you would like to be part of a successful team, then you could be what our client is looking for in a QC Lab Supervisor role. This is an excellent opportunity that offers a competitive compensation package. Relocation assistance available! If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com 

 

Job Description-QC Laboratory Supervisor-2nd Shift:

Perform and/or supervise analytical testing in our analytical testing lab. This position will report to the quality organization. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures
Schedule samples for analysis
Support specialized projects
Organize the receiving, storing and logging in of samples from the clean room or inventory
Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.  Must have the ability and experience to draft submission ready responses to audit observations.
Review and approve data generated by biologists
Maintenance of Laboratory Notebooks
Review and initiate the revision of  standard operating procedures
Active knowledge of current regulatory process and updates in the area of responsibility
Coordinate Instrument maintenance with Laboratory Metrology
Coordinate Method Transfers and Method Development
Write and execute protocols and reports
Understand OOS/Investigative reports
Develop Quality Reports
Mentor and Supervise Biologists and Technicians
Actively participle in New Initiative involving Lab topics
 

Requirements-QC Laboratory Supervisor-2nd Shift

B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 1 years of supervisory or team lead experience of multiple staff members.
Experience in FDA regulated industry.
Actively participated in audits (internal and regulatory) with independent close out of observations
Effective organization and planning skills
Excellent technical and verbal skills
Must have the ability to multi-task
Have problem solving skill set
Computer knowledge of data collection systems and or spreadsheet software, Microsoft Word, Excel, and PowerPoint
Understanding and experience utilizing the USP Compendia methods
Knowledge of Environmental Monitoring Programs A PLUS!
Knowledge of Aseptic Technique A PLUS!
Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis.
Ability to travel up to 10%

 

Apply Now!  Send resumes to tim@pointonerecruiting.com     

 

 

 

Recruiter Name: 
Tim Borop
Recruiter Phone: 
(262) 886-8000 ext. 218

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