Manager, Quality Assurance

Sharp Packaging Services•Allentown, PA

12h

About The Position

SUMMARY Responsibilities include supervision of quality activities, assessment for new and ongoing projects, provide direction for cGMPs to direct reports. Responsible for contact with QA representatives from each customer regarding quality issues related to documentation, inspection and packaging process. Participate in audits by customers and other regulatory agencies. Responsible for ongoing contact with internal Operations, Sales, Engineering and Quality Department employees concerning compliance with customer requirements as well as cGMP’s specific to the site. Scope of the position is focused on the Allentown facilities. 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 all-inclusive list of responsibilities may be distributed to multiple supervisors/managers. Other duties may also be assigned. Supervise quality functions including 3 shifts of employees, label production, in-process inspections and finished product inspections. Participate in internal, regulatory and customer audits and customer visits at the discretion of management. Follow-up on all customer audits specific to the site including assisting in the audit response and monitoring commitments specific to the related areas in quality. Investigate deviations related to procedures, policies, specifications or protocols. Participate in regulatory inspections of the local site at the discretion of senior management. Investigate consumer complaints related to packaging that are received from customers specific to related areas. Review and revise or establish SOPs on a designated basis to ensure accuracy and compliance for the organization. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management. Oversee and document the training of floor staff to ensure job functions are clear. Management of the Label Room and staff for the creation and printing of labels and Batch Record preparation/printing prior to production. Responsible for the completion of Environmental Samples in compliance the Environmental Monitoring program Ensuring that quality equipment is in compliance with calibration program. Assist with the development of Master Packaging Records to compliance with accurate and traceable packaging processes. Review and Approval of Change Controls, Temporary Change Controls, Bill of Materials for accuracy and compliance to requirement. Review and approval of Floor related Deviated Material Reports SUPERVISORY RESPONSIBILITIES: Direct supervision of quality assurance floor inspectors at the local sites. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and problem resolution.

Requirements

Bachelor’s degree in Science (BS/BA) from a four-year college or university preferred; or five (5) to ten (10) years-related experience and or training; or equivalent combination of education and experience.
Knowledge of FDA regulations including cGMP’s and current industry practice required.
Thorough knowledge of quality control/assurance and/or operations required.
Above average written and oral communication skills required.
Above average organizational and planning skills required.
Ability to read and interpret common scientific data.
Ability to respond to common inquiries or complaints from customers
Ability to direct and respond to inquiries from peers and subordinates.
Ability to effectively present information to the following groups:
Internal: Frequent contact with Quality Department, Project Managers, Account Planners and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer quality issues and cGMP issues.
External: Frequent contact with customer representatives conducting audits, planning new product introductions, addressing technical agreements and problem-solving quality issues specific to the site.
Good organizational skills are necessary.
Good mental skills for analysis and problem solving are needed.
Must be proficient in Microsoft Office Suite.

Nice To Haves

Knowledge of DEA regulations desired.
Broad knowledge of current pharmaceutical industry including packaging practices desired.

Responsibilities

Supervise quality functions including 3 shifts of employees, label production, in-process inspections and finished product inspections.
Participate in internal, regulatory and customer audits and customer visits at the discretion of management.
Follow-up on all customer audits specific to the site including assisting in the audit response and monitoring commitments specific to the related areas in quality.
Investigate deviations related to procedures, policies, specifications or protocols.
Participate in regulatory inspections of the local site at the discretion of senior management.
Investigate consumer complaints related to packaging that are received from customers specific to related areas.
Review and revise or establish SOPs on a designated basis to ensure accuracy and compliance for the organization.
Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by senior management.
Oversee and document the training of floor staff to ensure job functions are clear.
Management of the Label Room and staff for the creation and printing of labels and Batch Record preparation/printing prior to production.
Responsible for the completion of Environmental Samples in compliance the Environmental Monitoring program
Ensuring that quality equipment is in compliance with calibration program.
Assist with the development of Master Packaging Records to compliance with accurate and traceable packaging processes.
Review and Approval of Change Controls, Temporary Change Controls, Bill of Materials for accuracy and compliance to requirement.
Review and approval of Floor related Deviated Material Reports
Direct supervision of quality assurance floor inspectors at the local sites.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and problem resolution.