BPM Process Specialist

Zoetis•Lincoln, NE

1d•Onsite

About The Position

Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow. Benefits Include: $500 Sign on Bonus 4 weeks accrued paid vacation and 13 paid holidays. 401(k) match with company profit sharing. Tuition reimbursement and Student Loan repayment program. Great Health, personal, and family benefits starting day 1. 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, auditioning 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. Hours: 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.

Requirements

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.
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
Manual dexterity using hands and fingers.
Constant standing or sitting for extended periods .
Frequent need to sit, kneel, crouch, and climb; reach with hands and arms.
Capable of lifting up to 50 pounds
Ability to work flexible hours including work weekend, holiday, and overtime
High noise levels Hearing Protection as required.
Frequent exposure to heavy items ANSI 75 Safety shoes required.
Exposure to cleaning agents/chemicals PPE as required.
Exposure to moving mechanical parts Ensure safety shields are always in place.
Exposure to extreme temperature variations PPE as required.

Nice To Haves

Associate or Bachelor’s degree in Business Administration, or related disciplines applicable to production planning and pharmaceutical manufacturing preferred.
Familiarity with manufacturing process
Knowledge in MODA
Knowledge in Trackwise
Knowledge in Ariba

Responsibilities

Responsible of printing production batch record and associated labels per sampling plan.
Responsible of 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 of 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 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.