Manufacturing Support Specialist Full Time NEW

About The Position

Requirements

• Associate’s or Bachelor’s degree in a scientific, technical or related field
• Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance preferred
• At least 2 years of related experience in a GMP manufacturing environment
• Knowledge of GMP manufacturing, required. Knowledge of biologics or biosimilars preferred.
• Excellent oral and written communication skills required. Technical writing ability and document editing skills preferred.
• Ability to work effectively in fast-paced, cross-functional environment
• Strong attention to detail and commitment to accuracy
• Proficiency with standard office software, experience with electronic document or quality management systems preferred.
• Collaboration and teamwork
• Quality and compliance focused
• Problem-solving and initiative
• Accountability and reliability
• Adaptability and flexibility

Nice To Haves

• Background in Manufacturing, Process Engineering, MSAT, Technical Services, or Quality Assurance
• Knowledge of biologics or biosimilars
• Technical writing ability and document editing skills
• Experience with electronic document or quality management systems

Responsibilities

• Provide daily administrative support to the Manufacturing Manager, including scheduling, coordination of activities, and preparation of reports
• Facilitate communication between Manufacturing and cross-functional departments such as Quality Assurance, Quality Control, Supply Chain, and Facilities
• Assist with tracking departmental metrics and compiling data to support operational decision-making
• Draft, revise, and review controlled GMP documents including Standard Operating Procedures (SOPs), batch records, and training materials
• Ensure document accuracy, compliance, and alignment with internal quality standards and applicable regulatory requirements
• Manage document routing, approval workflows, version control, and archival within the documentation management system
• Assist in the development, coordination, and delivery of training for new and existing employees.
• Support onboarding activities, including orientation documentation, training assignments, and competency tracking.
• Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.
• Support Corrective and Preventive Action (CAPA) activities, including data collection, documentation, tracking, and follow-up.
• Assist with investigations by gathering relevant data, compiling summaries, and supporting root-cause analysis efforts.
• Contribute to change control processes by preparing or updating impacted documents, tracking deliverables, and ensuring timely completion.
• Participate in internal audits, compliance reviews, continuous improvement initiatives, and regulatory inspections as assigned.
• Provide hands-on support in cleanroom operations during periods of increased demand, staffing gaps, or special projects. Cleanroom operational support may require working 1st shift or 2nd shift.
• Adhere to all cleanroom, gowning, aseptic, and safety procedures.
• Assist with production activities, equipment setup, material handling, and other operational tasks as assigned
• Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
• Assist with implementation of new systems, tools, and process improvements.
• Work with operations team to create a culture of accountability, ownership, and continuous improvement.
• Respect all safety, laboratory policies, and practices on site.
• Work across departments and/or sites.
• Work with process engineers and leadership to align the priorities of the team with those of the department.
• Able to work independently; shows initiative and able to work with all levels of staff.