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14 days old

Shift Lead - Aseptic Operator - Pharmaceutical Manufacturing

Kelly Services
Bedford, OH 44146
**Lead Aseptic Operator**



Bedford, OH



Direct Hire/Hourly





**Dayshift Schedule:** 6am-6pm 4:3:3:4 Rotation



**Night Shift Schedule:** 6pm- 6am, 4:3:3:4 Rotation




The contents contained in this job description are the minimum requirements required to be met for the aforementioned position. Under the direction of area management or designee, the Shift Lead is responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products at plant.


**Key Responsibilities**




+ Perform job functions with in compliance of 21CFR part 210 and 211, FDA, OSHA and other regulatory agencies.

+ Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.

+ Ensure training compliance for assigned curriculum prior to performing any work task

+ Candidate will be required to assist in the authoring and revision of departmental SOPs.

+ Candidate will lead as required in the training of operations personnel.

+ Candidate will serve as supervisory liaison for assigned shift.

+ Candidate will assist in the scheduling of shift/daily/weekly tasks in conjunction with area supervisor.

+ Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, parts washers, filler, capper, CIP/SIP skid, etc.

+ Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely fashion

+ Assist in the execution of equipment/process qualification, validation, and protocols as required.

+ Assist in development and creation of departmental procedures to include but not limited to SOPs, OJTs, and work instruction documents

+ Participate in investigations, and execute appropriate approved corrective / preventative actions for Aseptic Core related processes.



**Education/Experience**




+ Required: HS Diploma/GED and 7+ years applicable experience

+ Preferred: Bachelors of Science or Engineering

+ Advanced computer skills proficiency

+ Military service highly desirable

+ Automation and controls experience preferred

+ Demonstrated process/equipment troubleshooting experience required

+ Demonstrated ability to organize and lead small teams




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-16 Expires: 2020-11-16

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Shift Lead - Aseptic Operator - Pharmaceutical Manufacturing

Kelly Services
Bedford, OH 44146

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