MCS Manufacturing Associate

Remote Full-time
About the position

Responsibilities
• Executing drug product packaging and assembly activities.
• 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.

Requirements
• High school/GED + 2 years Manufacturing or military experience OR Associate's + 6 months Manufacturing or military experience OR Bachelor's.

Nice-to-haves
• 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.

Benefits
• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements, where possible.

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