Quality Specialist - 2nd Shift

Sharp Packaging Services•Allentown, PA

4d•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 for supporting, designing, and implementing 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. A working knowledge of FDA regulations pertaining to Pharmaceutical / Pharmaceutical Packaging Operations is required. The scope of the position includes Allentown, Macungie, and/or Conshohocken. Decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss.

Requirements

Working knowledge of FDA regulations pertaining to Pharmaceutical / Pharmaceutical Packaging Operations.
Experience in inspection of Pharmaceutical or related industry is required.

Nice To Haves

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 of the organization when required.