Quality Auditor Fixed Term Contract

This is an onsite position requiring the team member to be onsite for all scheduled workdays. No relocation assistance is provided for this opportunity. Sponsorship is not provided for this opportunity.

This position is a fixed-term contract projected to last 9 months. The position offers benefits training and full time hours. A $1000 bonus will be offered at 12 & 24 weeks for those that complete these milestone dates.

Shift Hours: Sunday Monday Tuesday Every Other Wednesday 5:45 AM - 6:00 PM

At West were 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 Wests indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future

Theres no better place to join an inclusive community of professionals with opportunities for lifelong learning growth and development. 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.

Job Summary

The role is essential in ensuring in-process and finished products meet customer specifications. This role provides total manufacturing quality inspection services including quality inspection quality control sampling inspection documentation and record keeping. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.

Essential Duties and Responsibilities

• Perform sampling inspections and testing of in-process and finished goods products per applicable procedures and AQL plans utilizing both visual means as well as calibrated test equipment to include laser micrometer optical comparator and other equipment as applicable.
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site.
• Understand and follow applicable ISO standards requirements.
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices.
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing scanning etc.) as necessary.
• Print documents from Master Control shopfloor or other software program and manages documents related to the Quality System.
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
• Generate rejection and deviation reports as directed by site.
• Perform trace back investigation of nonconforming raw material and product as directed by site.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations policies work procedures instruction and all safety rules.
• Exhibits regular reliable punctual and predictable attendance.

Additional Responsibilities

• Provide a Customer Service attitude when interacting with internal and external customers while accomplishing work production and achieving quality standards.
• Maintain a clean orderly and safe workstation and environment at all times.
• Conform with and abide by all regulations policies work procedures instruction and safety rules.
• Exhibit regular reliable and punctual attendance.
• Perform other duties as assigned based on business needs.
• Keep current with new GMP compliance guidance and internal QA procedures.
• Support new GMP compliance guidance and Data Integrity initiatives.

Education

• High School Diploma or GED Required

Work Experience

• 1 year manufacturing experince required.
• Basic computer skills.

Preferred Knowledge Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Possess ability to work independently and as part of a team with self-motivation adaptability and a positive attitude.
• Willingness to learn new and review new analytical techniques.
• Meet individual and departmental goals as required.

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs of force occasionally and/or negligible amount of force frequently or constantly to lift carry push pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time.

Light-Exerting up to 20lbs/9kg of force frequently and/or negligible amount of force frequently constantly to move objects.

Additional Requirements

• Ability to learn understand and remember normal tasks.
• Ability to hear speak and understand conversation in English.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task work under time constraints problem solve and prioritize.
• Read and interpret data information and documents.
• Work under deadlines with constant interruptions.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race religion color national origin gender sex gender identity sexual orientation age marital status veteran status or disability status. If you have a special need that requires accommodation in orderto apply to West please send an email to . Where permitted by law an offer of employment with West Pharmaceutical Services or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of background screening.

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Required Experience:

IC