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MCS Manufacturing Associate
Posted: 08/22/2024
2024-08-22
2024-12-11
Employment Type:
Contract
Job Category: Manufacturing
Job Number: 3937
Job Description
The Manufacturing Associate position is part of the Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection. This Associate position will be focused on manual visual inspection.
Responsibilities:
Responsibilities:
- Under minimal supervision, performs manufacturing according to Standard Operating Procedure
- Understand process parameters and can identify process anomalies
- Operate critical processing equipment
- Assist in ensuring operations are completed per manufacturing schedule
- Resource related to processing operations on the mfg. floorResponsible for identifying and communicating problems during operations
- Review, revise, and audit documents
- Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
- Recognizes and escalates problems
- Able to establish working relationships with others outside area of expertise
- Ability and willingness to support flexible shift structure in support of operations (may include weekend)
- Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position
- Organizational skills and an ability to perform assignments with a high degree of attention to detail
- Written and oral communication skills.
- GMP knowledge with ability to interpret and apply applicable regulations
- Ability to understand analytical methods for manufacturing/laboratory area
- Bachelor’s degree and minimum 1 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- Associate degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
- Prior experience with computers, and intermediate mathematical skills
- Experience with manual visual inspection or in a GMP regulated environment.
- Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
- Knowledgeable of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
- Demonstrated ability to work in a team and professional environment.
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