Job description

Title: Manufacturing Associate II (PERM)

Location: Norwood, MA

Salary: Fulltime/ Permanent role

The Role:
Client is seeking a cGMP Manufacturing Associate II, in the Fill Finish Operations, Drug Product group responsible for final sterile filtration, vial filling, visual inspection, label and packaging (Fill Finish) of mRNA Drug Products. This position is located at GMP Manufacturing site in Norwood, MA.

Here’s What You’ll Do:

• Independently executes sterile filtration, filling, visual inspection, labeling and packaging using disposable technologies, automation, and Manufacturing Execution Systems (MES).
• Demonstrates applicable and specific knowledge of standard manufacturing practices and equipment.
• Tracking and reorder of all filling, labeling, and packaging materials.
• Leads/participates in fill finish activities for multiple drug product vial types and packaging configurations.
• Collaborate with Supply Chain, maintain inventory and review process orders.
• Closely partner with QA and QC peers for execution of fill finish activities.
• Responds rapidly and trouble-shoots routine equipment process and digital issues.
• Maintain individual training compliance as well as train others in the manufacturing process.
• Ensure strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
• Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Lead/participate in multiple projects in a fast-paced environment and drive for continuous improvement.
• Effectively collaborate in a dynamic, cross-functional matrix environment.
• Adhere to and reinforce gowning procedures and maintain a clean general operating area.
• Flexibility to work off hours and overtime if needed to meet clinic demand and process schedules.

Here’s What You’ll Bring to the Table:

• Associates Degree, Biotechnology Certificate, Bachelor of Science with cGMP with 3-5 years of experience or 7+ years of relevant experience.
• Ambitious and self-starting attitude to take on responsibilities and own process improvements.
• Experience in electronic batch records, Syncade, OSI PI, eDMS, and SAP preferred.
• Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP.
• Express core values: Bold – Curios – Relentless – Collaborative

Best Regards,

Vivek Kumar

IDC Technologies, Inc

Job Types: Full-time, Part-time, Contract, Temporary

Salary: $50.00 - $75.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Day shift
• Monday to Friday
• Night shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing (Preferred)

Shift availability:

• Day Shift (Preferred)
• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: One location

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