Document Control Specialist

CooperVision, Inc.; Victor (ID); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

CooperVision, a division of CooperCompanies, seeks a QA Document Control professional to execute QA review activities for change control and to revise SOPs/WIs. You will utilize the Agile eQMS to process approvals and review Change Orders, while supporting training and documentation integrity.

You will collaborate with Global Packaging, Site Operations, Supply Chain, IT, and other functions to ensure compliant document control at the Victor site and broader organization.

Formación

• Experience with document control in GMP or similar regulated environments.
• Ability to create and revise SOPs and work instructions.
• Proven collaboration with diverse, global teams to support changes.

Responsabilidades

• Execute QA review activities for change control elements across departments.
• Revise and create SOPs and WIs; use eQMS to process and approve documents.
• Review Change Orders, support training, and assist with deviations as needed.
• Interact with Global Packaging, Site Operations, Supply Chain, and IT.

Conocimientos

QA review

Change control

SOP

WI

eQMS

Agile

Document control

Cross-functional collaboration

Herramientas

eQMS

Descripción del empleo

At CooperVision, a division of CooperCompanies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com.

• This role is not eligible for employer-sponsored work authorization now or in the future. Applicants must be authorized to work in the United States on a permanent and ongoing basis without the need for future sponsorship (i.e., H1B, STEM OPT extensions, TN, etc.)
• This position requires full-time onsite work (5 days per week) in Victor, NY and is not eligible for relocation assistance.

Job Summary:

Responsible for executing required QA review activities for change control elements associated with local and global departments in support of the Quality Management System.

Will revise and create Standard Operating Procedures (SOP's), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts. Will utilize the Agile electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.

May participate in establishing procedures for local and global review of change packages as well as engineering changes, engineering studies, and validations when necessary.

May assist with the investigation of Quality Feedback (QFB's), and Non-Conformance Reports (NCR's) or other sources of quality data. May participate with packaging verifications and validations when necessary.

Responsible for management of all document control activities at the assigned site (Victor, NY or West Henrietta, NY). Regular interaction with different functional departments including Global Packaging, Site Operations, Supply Chain, IT, etc. as they interact with the eQMS system (Agile).