What are the responsibilities and job description for the Manufacturing Associate position at ApTask?
Position Details :
Job Title : MCS Manufacturing Associate
Location : Thousand Oaks, CA (Onsite)
Duration : 12 Months contract with possibility of extension
Job Summary
The position does require a passing eye exam for color.
Ideal candidates : 1 year minimum GMP background manufacturing, computer savvy, SAP Knowledge is helpful as candidate will need to use Manufacturing Execution System. Experience with manual visual inspection.
The Manufacturing Associate position is part of the Client, Thousand Oaks, 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. If candidate excels in inspection there may be opportunities to expand training to analytical testing.
Job Scope and 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. floor
Responsible 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
Preferred Qualifications :
Experience with manual visual inspection of drug product, analytical testing lab, or in a GMP regulated environment.
Experience with Client 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.
