QA Supervisor, Quality Operations - 2nd shift


Job ID 18-00015

Industry Pharma

Job Type Permanent

Location Decatur, IL

Description

 QA Supervisor, Quality Operations - 2nd shift
Location - Decatur, Illinois
Shift is 3:00 -11:00 Mon - Fri.
Full-time Benefits - Full
Relocation Assistance Available - Yes
Commission Compensation - No
Bonus Eligible - Yes
Overtime Eligible - No
Interview Travel Reimbursed - Yes
Security Clearance Required: No
Visa Candidate Considered: No
 
Ideal Candidate
Ideal person needs to have pharmaceutical manufacturing experience preferably in an aseptic environment. 
Will directly manage 3 - 4 employees with relatively little experience. 
Will need to be a hands-on Supervisor who enjoys mentoring others. 
 
Candidate Details
2+ to 5 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel – Never
 
Performs quality assurance duties to prevent or eliminate defects in products for sterile filling operation or in final inspection operation.  The QA Supervisor of Quality Operations schedules and reviews in-process auditing of all facility operations.  This individual will work in a detail oriented, compliant manner to ensure the facility operations align with policies and procedures as well as cGMPs.  The QA Supervisor of Quality Operation reports directly to the QA Manager of Quality Operations.
 
ESSENTIAL FUNCTIONS
•    Trains QA Technicians on proper technique and procedures.
•    Schedules auditing assignments to staff.
•    Reviews daily in process audit paperwork.
•    Documents and investigates deviations, and non-conformances
•    Assists in Annual Product Review/Annual Report Compliance
•    Monitors the production processes and ensure consistency of procedures.
•    Involvement in decision making to stop production if quality standards are not being met.
•    Oversees the verification of green release stickers issued to operations.
•    Oversees the automated inspection and AQL sampling of finished products.
•    Oversees the transfer of finished products to other facilities..
•    Reviews environmental monitoring of controlled areas.
•    Audits the maintenance of a clean sanitary environment.
•    Reviews and calculates theoretical yields for completed raw material records and cards.
•    Reviews mean kinetic temperature calculations
•    Reviews System Alarm Messages.
 
ADDITIONAL RESPONSIBILITIES
•    Works with CAPA Coordinator or designee to ensure items are completed, documented and timely.
•    Assists with CAPA effectiveness checks
 
SUPERVISORY RESPONSIBILITIES
•    Directly responsible for performance reviews, goal setting and personnel development plans for QA Technician I and II
•    Recruiting, interviewing and hiring qualified employees to fill open positions.
•    Addressing complaints and resolving personnel problems within the department
•    Maintaining confidentiality of information.
 



Qualifications

QUALIFICATIONS
Must be detail-oriented and possess the ability to work on multiple projects simultaneously. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
SAFETY REQUIREMENTS
Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility 
 
EDUCATION AND EXPERIENCE
•Bachelor's Degree (BS or BA) from a 4 year college or university
•5+ years demonstrated excellence in in the pharmaceutical or related industry
 
JOB PREREQUISITES
•All full-time employees are required to work a 40 hour week.  At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines.  All applicants must be able to meet the attendance standards.
 •Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's. 
•Strong verbal and written communication skills.  Resourceful and well organized.
•Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.