Manufacturing Specialist (Pharma/Biotech)

Job Scope:

To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality.

Responsibilities:

• Perform technical writing and investigation of non-conformances in collaboration with Operations
• Identify and put in place appropriate corrective and preventative actions in conjunction with Operations team Change Management
• Structure common Operations Training modules and Train new hires on such modules
• Trends Key Performance Indicators and implement measures to streamline work processes and procedures GMP Document Authoring and Revision
• Electronic Batch Record Co-Authoring, Revision and improvement
• Participates / leads operations improvements and new product introduction projects
• Work with Quality systems (e.g. CAPA and change plans) and Operations
• Related System (LIMS, SAP, PI, Maximo, MS Office)
• Assist in regulatory inspections, detailing investigations and change plans.
• Work on continuous improvement projects

About You:

• BS (or equivalent experience), with at least 2 to 5 years of relevant experience
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred
• Experience with cGMP documentation and record maintenance
• Experience with Regulatory inspections is required
• Strong ability to lead and drive cross functional teams
• Excellent attitude towards work, with strong drive to drive tasks to closure
• Agility, able to work under stress and cater to different priorities
• Good presentation and strong technical writing skills
• Good interpersonal and communication skills

Job Type: Contract
Contract length: 12 months

Pay: $4,000.00 - $6,500.00 per month

Schedule:

• Monday to Friday

Experience:

• Investigation: 2 years (Preferred)
• Pharmaceutical company: 2 years (Preferred)
• Upstream/Downstream: 2 years (Preferred)

Work Location: In person