1st Shift CGMP Biomanufactuirng

Hi,

This is Hershita working as Recruitment Specialist with Experis part of Manpower Group. Please have a look at the job description and if you are interested, please reply back with an updated copy of your Resume. Please send your updated resume to () and I will be happy to have this moving swiftly.

Contact # 414-666-8462 Extn 7147

Job Role: CGMP Biomanufacturing Training Specialist

Location: Madison WI 53717

Duration: 6+ Months. (Possibility for extension)

Job Description:

1st SHIFT - Mon - Fri 10 AM to 6 PM

2nd SHIFT - Mon - Fri 2 PM to 10 PM

This is NOT an HR position. This position provides guidance and ensures compliance in GMP training practices, documentation and Environmental Health and Safety. It would be equivalent to a Biomanufacturing/Manufacturing SME who will train new hires on SOPs, cGMPs, best practices etc. It will be an entry level role. Must have a min of 1-year experience training and GMP. Manufacturing or lab experience preferred.

This position works with Training Manager, cGMP Biomanufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance and Environmental Health and Safety to cGMP Biomanufacturing Group, assist with developing content and formatting training materials, developing and administering training programs for employees, assesses training and development needs for the cGMP Biomanufacturing Group, helps individuals and groups develop skills, safety and knowledge, creates training manuals, monitors training for effectiveness.

Specific Duties, Activities, and Responsibilities:

Track/monitor training and provide timely, accurate information and reports to Training Manager including metrics actions needed to ensure compliance

Actively lead training sessions

Assist in conducting needs assessment to determine training requirements. Works with managers to address learning issues, instruction problems, or new educational needs regarding specific employees or groups

Assist in developing qualifications/evaluations to ensure training effectiveness in the MFG department

Assist to design and develop training including structured job specific tasks, SOP training, FDA cGMP, Environmental Health & Safety regulations, and general work skills as needed

Revises materials based on assessment/evaluation findings/outcomes

Partners/collaborates with Subject Matter Experts to identify need, target audience and desired performance standards

Assists in improvements for safety and provides on the floor manufacturing support.

Assist Quality Assurance department with SOP training as needed

Participate in team meetings

Track/review training records for accuracy and completeness.

Informs personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.

Maintain effectiveness of Quality system as it pertains to cGMP and training requirements

Assists in general cleanroom housekeeping and adherence to 5S standards

Assist in execution of equipment qualification/validation protocols, as required

Ability to work scheduled shift and other off-shift coverage as required

Other duties as assigned

Education:

B.S./B.A. in Biology, Chemistry or other related scientific field, with minimum of 1-2 years' experience in related laboratory work

Required:

Biomanufacturing or other Pharmaceutical/Medical Device experience

Clean room, aseptic technique, and/or general lab equipment experience

cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge

Following standard operating procedures

Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment

Preferred

Commercial Biomanufacturing experience or other Pharmaceutical/Medical Device experience

Prior ISO 6/7/8 cleanroom experience

Prior dedicated training experience

Experience with Trackwise, Compliance Wire or other electronic tracking software

Technical Requirements:

Ability to work within ISO 6/7/8 clean room environments

Ability to use Excel, Word, and other MS Office applications

Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy

Ability to peer review data to ensure data is well organized with complete documentation

Ability to understand and independently apply cGMPs to everyday work with regards to documentation and equipment use

Ability to operate within a clean room environment (ISO 6/7/8) and provide on the floor support