Quality Specialist

Sharp Packaging Services•Allentown, PA

6d•Onsite

About The Position

The Quality Specialist provides quality oversight, GMP guidance and support, and makes quality-related decisions for designated functional areas within Sharp Commercial sites. They work closely with internal teams daily and occasionally represent Sharp Quality in customer interactions. The Quality Specialist is responsible to support, design, and implement GMP initiatives and continuous improvement opportunities within the Quality Operations organization through data analysis, training, motivation, and coaching in collaboration with internal and external stakeholders. Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss.

Requirements

Experience in inspection of Pharmaceutical or related industry is required.
Ability to apply moderately complex mathematical operations including an understanding of statistical skills.
Ability to effectively communicate (written and verbally) with the following groups: Internal Communication: Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering teams. External Communication: Represents Quality as the subject matter expert (SME) for customers and regulatory agencies on Quality Operations related processes and issues.
Above average writing and verbal skills, ability to provide clear, concise and legible communication within written procedures, internal and external correspondence, such as memos to file, electronic mail and Non- Conformance and procedure writing.
Ability to make independent rational decisions pertaining to Quality and Compliance is required.
Ability to resolve problems effectively and efficiently.
Intermediate Windows applications including the Microsoft Office Suite and electronic QMS.

Nice To Haves

Bachelor’s degree is preferred with one to three years related experience or Associates Degree with three to five years of related experience.
Outside certification of quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.

Responsibilities

Actively participate in non-conformance investigations that identify robust root cause and effective CAPA and Continuous Improvement planning.
Review and approve quality documentation such as forms, work instructions, shipping requirements, specifications, etc.
Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
Support customer relationships related to Quality as needed.
Proactively identify and facilitate resolution of potential risks.
Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
Implement methods for process control, process improvement, testing and inspection.
Ensure testing and inspection meet internal and external requirements.
Audit internal processes on shop floor and warehouse and support internal stakeholders (operations, sales, customer service, project management, validation, and engineering) to ensure compliance of processes and product.
Perform periodic review of room / equipment logbooks and Master Packaging Records for completeness and accuracy.
Author, review and / or approve quality documentation including work instructions, SOPs, Quality Forms, etc.
Provide Regulatory and Customer Audit Support /assist in providing observation response.
Collect and distribute internal and Customer KPIs as required.
Assist with testing equipment calibration to ensure timely calibration and repair.
Support DEA requirements and DEA Compliance.
Verify Major/Minor cleans when required.
Proactive review of new quality inspection processes/procedures with operations and technical operations.
Perform In process inspections and AQL sampling as needed.
Support training department to implement new opportunities for training program.
Ability to simultaneously manage multiple tasks.
Must be flexible to meet the needs to the organization when required.