MCS Manufacturing Associate

Executing drug product packaging and assembly activities, respectively.
Support planning & organization (time, staff, lines, materials, equipment).
Organize and lead team meetings.
Supporting problem-solving sessions by serving as SME as needed.
Divide work/tasks by providing clear guidance and instructions to the team.
Drive continuous improvement with the team and act as coach for production activities.
Collaborate with Line Owner and FLM on process/equipment investigations.
Fill gaps in the production lines and support as required.
Performing initial review of manufacturing batch records.
Maintaining a safe environment while adhering to compliance standards and by identifying additional preventative measures.
Crafting and/or revising standard procedures.
Elevating critical and impactful events to management.
Utilizing appropriate systems for job duties (SAP, MES, QMTS, and LIMS etc.).
Provide SME support to Line Owners and NPI leads as needed.
Initiating quality records and supporting triage.
Assembly of a variety of combination products such as Auto Injectors and Automated Mini Dosers utilizing Semi-Automated Assembly Equipment.
Bottling of small molecule tablets via manual process or automated processing.
Assembly of vial sleeve and label and packaging of -70-degree C product.

CFR and Regulatory knowledge.
Mechanical ability.
Knowledge of WIP lab equipment and computers.
Basic statistical mathematical skills.
Ability to interpret and apply GMP knowledge.
Understanding of analytical methods for manufacturing area.
Ability to understand and apply basic chemistry, biology and physical principles.
Basic troubleshooting skills on Purification equipment.
Excellent written and verbal communication skills with the ability to effectively communicate thoughts and ideas.
Ability to prioritize tasks and work in a challenging and fast-paced work environment.