Quality Tech - Pipeline

About the role

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development.

Responsibilities

• Performs receiving inspections, start-up inspections, in-process and final inspections.
• Completes documentation & reviews production records.
• Performs analytical testing on various materials.
• Troubleshoots and solves technical problems.
• Programs and operates automated inspection equipment.
• Prepares shipping documentation & documentation audits.
• Inspects and releases incoming materials.
• May perform analytical testing, evaluates, records and reports on the chemical and physical properties of various substances and materials to determine product release approval status.
• Reviews and approves Batch Production Records from each job.
• Composes Non-Conformance Report (NCR) Deviations, Document Change Notices (DCN), Out of Specification (OOS), Work Instructions, Incoming Quality Control (IQC) forms and Engineering Change Requests (ECR’s).
• Assists in the design & drawing reviews and makes recommendations for improvements, clarification, and correctness as needed.
• Assists shift personnel with quality issues and/or measurement techniques.
• Inputs incoming lots into expiration/retest database.
• Maintains expiration/retest date database for incoming materials.
• Reviews retest dates and arranges for testing of materials for retest.
• Reviews expiration dates and arranges for disposal of expiring materials.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Performs other duties as assigned.

Requirements

• Education: High School or equivalent.
• Work Experience: Less than 3 years of experience.

Physical Requirements: While performing the duties of this job, the associate frequently is required to sit, walk, stand, balance, stoop, kneel, or crouch to support production needs. The associate may lift and/or move up to 25 pounds and occasionally lift and/or move more than 55 pounds.

Qualifications

• Knowledge and experience with FDA and ISO Quality Systems to include SPC and calibrations systems.
• Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
• Experience with ISO 9000 standards and GMP’s.
• Must be able to prioritize and perform position responsibilities accurately and meet required deadlines.
• Strong attention to detail.
• Strong problem identification/analysis and solving skills with hands-on approach.
• Excellent verbal and written communication skills.
• Maintain an organized and clean quality Lab.
• Ability to multi-task and prioritize in a fast-paced environment.
• Ability to interface with all personnel levels.
• Motivated self-starter with ability to work independently on multiple assignments in a team environment.

Benefits

Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Schedule

Shift 2- Every other Saturday, Sunday, Monday, Tuesday (5:45PM to 6:00AM)