
Operations Support Specialist
1 week ago
- Coordinate and own the repetitive IDA grant submission for the operations team.
- Ensure adequate trending, tracing and logging of all admin activity related to bi-yearly IDA submission.
- Provide administrative support to the operations, manufacturing, and quality teams.
- Maintain and update production and inventory records in ERP/MRP systems.
- Coordinate scheduling and tracking of production orders and material movements.
- Assist with documentation control including SOPs, batch records, and manufacturing instructions.
- Prepare operational reports and metrics (daily, weekly, monthly).
- Support internal audits and regulatory inspections (FDA, ISO, etc.) by organizing and retrieving required records.
- Track and order supplies and consumables for manufacturing and cleanroom environments.
- Coordinate cross-functional meetings, take minutes, and follow up on action items.
- Assist with onboarding and training logistics for new operations staff.
- Support health, safety, and environmental compliance activities, including maintaining training records and reporting incidents.
- Update graphs for forums.
- Create IT tickets.
- Maintain a filing system for data required by operations.
- Compile forms such as parental, paternity, force majeure etc.
- Prepare regular reports and presentations, e.g. absence reviews.
- Assist in paperwork for reworks in operations.
- Raise PO's as required.
- Employee communications.
- Assist with aged orders, slow moving and inventory counts.
- Associate's or Bachelor's degree preferred (business, operations, life sciences, or related field).
- 4 + years of experience in an administrative or operations support role, preferably in a regulated manufacturing environment.
- Familiarity with medical device regulations (FDA 21 CFR Part 820, ISO 13485) is a plus.
- Strong organizational and time-management skills.
- High attention to detail and accuracy.
- Proficient with Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
- Experience with ERP systems (SAP, Oracle, etc.).
- Excellent verbal and written communication skills.
- Ability to work independently and within a team.
- Problem-solving attitude.
- Be a proven team player.
Pay rate will not be below any applicable local minimum wage rates.
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