BPM Process Specialist

Position Summary

The candidate will be responsible for supporting various activities within Fill and Finish operations such as: printing batch records, assembling sampling plan and labels, auditing closing process in SAP, GMP review of the batch records, audit of the batch records and logbooks, CAPA and change management, updating SOPs. Understand, follow, and complete process documentation in support of GMP. Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.

This position will report directly to the manufacturing team, presence on the manufacturing floor expected as well as supporting manufacturing business needs occasionally.

1st Shift, Monday - Friday 8 hrs/day, 40 hrs/week 6:00am - 6:00pm. Hours to be set by management. Overtime, weekends, and holidays may be required.

• Responsible for printing production batch records and associated labels per sampling plan.
• Responsible for the production batch record GMP review and 100% right first-time goal achievement in a timely manner.
• Assist with batch records manufacturing corrections.
• Indicate the change control to corresponding batch records and redline executable batch records.
• Review logbooks and ensure accuracy.
• TECO and COOISPI of batches
• Perform MUV analysis and recommend BOM and recipe changes. Assist with deviation investigation and write-up (manufacturing and environmental investigations) and change control management.
• Responsible for related manufacturing CAPA implementation.
• Understand, follow, and complete process documentation in support of GMP.
• Train colleagues on GMP documentation and ensure team compliance during execution and throughout review of the batch records.
• Act as a liaison and collaborate with quality assurance and manufacturing team leaders to ensure respect of GMP practice and appropriate CAPA defined.
• Assist with authoring and updating SOPs.
• Perform RID submission.
• Order expense-based material as needed using Ariba system.
• Assist as needed the production team with production tasks per business needs.
• Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.

Education and Experience

• Required High School graduate or equivalent.
• Demonstrate basic mechanical skills.
• Demonstration of personal computer usage.

Minimum 3-5 years of relevant experience in production and manufacturing support.

• Experience in a pharmaceutical or regulated manufacturing environment preferred.
• Preferred Associate or Bachelor's degree in Business Administration, or related disciplines applicable to production planning and pharmaceutical manufacturing preferred.

Language

Skills:

• Demonstrate good communication skills.
• Read, interpret, and apply safety procedures, standard operating procedures, maintenance instructions, and departmental procedures.
• Communicate effectively with peers and Team Leader
• Document steps accurately and legibly.

Mathematical

Skills:

• Add, subtract, multiply, and divide in all units of measure.
• Perform conversions within the metric system.
• Complete controlled documents and inventory calculations using basic math.
• Ability to set up and use basic weight devices in standard and metric format.

Reasoning Ability:

• Understand and apply instructions in written, oral, and/or diagram formats.

Functional skills:

• Ability to read and follow written directions.
• Ability to communicate effectively both verbally and in writing.
• Ability to think critically.
• Ability to function independently when required.

Technical skills:

• Basic computer skills (Word and Excel)
• Proficiency in SAP

Ability to troubleshoot.

• Knowledge in GMP environment

Desirable skills:

• Familiarity with manufacturing process
• Knowledge in MODA
• Knowledge in Trackwise
• Knowledge in Ariba

The physical demands described here are representative of those that must be met by an employee to successfully perform the principal duties of this job. Reasonable accommodations may be made to enable individuals with disabilities…