Senior Quality Specialist

SUMMARY:

Senior Quality Specialist provides quality oversight, GMP guidance and support and makes quality-related decisions for the designated functional areas within Sharp Commercial sites.  They work closely with internal teams and customer quality representatives on a routine basis.  The Senior Quality Specialist serves as a Quality SME and are responsible for leading, 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. Must possess strong working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Senior Quality Specialist.  Other duties may also be assigned.

• Collect and summarize data, draw conclusions, turn recommendations into clear communication. Turn data into improvements by facilitating and driving actions from analysis.
• Lead and take active role in non-conformance investigations that identify robust root cause and effective CAPA and Continuous Improvement planning.
• Manage relationships with customers, ensuring quality standards are aligned, and meeting customer needs.
• Review and approve Master Packaging Records for new projects and existing records for updates and all corresponding documentation.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Identifies issues and can independently assess the need for non-conformance and utilizes good judgement and rationale to determine the appropriate containment actions in conjunction with operational leadership.
• Proactively identify and facilitate resolution of potential risks.
• 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.
• 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.
• Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls.
• Collect and present customer KPIs as required.
• Oversee testing equipment calibration to ensure timely calibration and repair.
• Support DEA requirements and DEA Compliance
• Support training department to identify new opportunities for training program.
• Train colleagues
• Ability to serve as the alternate for the Quality Manager role during Manager’s absences as requested.
• Provide support to the audit team for items relevant to quality processes and procedures.
• Ability to simultaneously manage multiple tasks.
• Must be flexible to meet the needs of the organization when required.

SUPERVISORY RESPONSIBILITIES:

Indirectly provides guidance and leadership to the Quality Specialists and Quality Line Associates on the shop floor.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal supervision. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

REQUIREMENTS:

Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree is preferred with three to five years related experience or associate’s degree with five to seven years of related experience or a minimum of seven years of related