Quality Ops Specialist: Labeling & Artwork

Katalyst-Healthcares-; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Systems Senior Specialist to design and deliver QA metrics across GxP operations. You will support packaging/labelling validations, manufacturing operations, and new product launches at CMOs, reviewing validation docs, batch data, deviations, and change controls.

Ideal candidates have a science/engineering background with 3+ years of QA experience, strong attention to detail, and the ability to communicate with stakeholders in a fast-paced

Qualifications

• Bachelor's degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience.
• Experience with Finished Goods/Packaging/Labelling preferred.
• Experience with Commercial Validation (especially packaging validation) preferred.
• Strong attention to detail and ability to work independently in a fast-paced environment.
• Excellent communication skills and a drive to contribute to quality improvements.

Responsibilities

• Reviews validation documentation.
• Performs final review of executed batch records and resolves comments with the CMO.
• Reviews master batch records for validation and launch, ensuring changes are documented in the QMS.
• Ensures presence and acceptability of all required documentation prior to batch release.
• Reviews and approves investigations, CAPAs, and change controls for external programs.
• Support day-to-day management of lot disposition processes.
• Communicates proactively with internal and external stakeholders and management.
• Maintains files for quick retrieval and supports monthly/quarterly QMS metrics reporting.

Skills

Attention to detail

Self-motivated

Independent worker

Effective communicator

Fast-paced environment

Education

Bachelor's degree in science/engineering/health

Tools

Veeva

Job description

General Position Summary :

• The Quality Systems Senior Specialist supports design and delivery of impactful metrics and analyses across GxP operations.
• The incumbent plays a vital role in delivering actionable insights to quality leadership teams that support demonstration of appropriate quality oversight and prompt evaluation of trends and deviations from expected results
• The Operational Area Senior Quality Specialist works with a high degree of independence to provide QA support of packaging/labelling validations (primary & secondary packaging as well as serialization), manufacturing operations, and new product launches at external contract manufacturing organizations (CMOs).
• This role will review validation documentation, batch data, deviations, change controls, and other quality systems documentation in support of validation and product disposition.

Key Responsibilities:

• Reviews validation documentation
• Performs final review of executed batch records, resolves comments with CMO
• Reviews master batch records for validation and launch, verifying that all changes are appropriately documented in Vertex's QMS.
• Ensures presence and acceptability of all required documentation prior to batch release.
• Reviews and approves investigations, CAPAs, and change controls for external programs.
• Support day to day management of lot disposition process as needed.
• Communicates proactively with internal and external stakeholders and management.
• Maintains files such that documents are readily available and easily retrievable.
• Assists department with monthly/quarterly Quality System metrics and reporting.

Education And Experience:

• Bachelor's degree in a scientific, engineering, or allied health field and 3+ years of relevant work experience, or comparable background.
• Experience with Finished Goods/Packaging/Labelling preferred.
• Experience with Commercial Validation (especially packaging validation) preferred.
• Strong attention to detail.
• Self-motivated, independent, organized, and an effective communicator.
• Has the ability to navigate a fast-paced work environment.
• A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.

Preferred Qualifications:

• Small molecule primary & secondary packaging validation and product launch experience in the following markets: US, CA, EU/UK, AU, CH, IL, BR & RU.
• Technical experience and engineering background
• Experience leading complex projects/teams and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

Must Submit with the following:

• PHOTO ID.
• Month and day of birth.
• Valid U.S. permanent address.
• (2-3) references from past managers with their "Company Emails ".

Additional Notes For Suppliers:

• FG + Artwork referenced would be an excellent 'green flag'.
• FG Packaging typically would require some level of Artwork Management.
• If we are consistently looking for those qualifications we may find some relevant candidates.
• It will also be a plus is the person has experience investigating deviations related to artwork management and running in Veeva or a similar systemand experience in continuous improvement processess.