Job Description

Responsibilities include supervision of quality activities, assessment of new and ongoing projects, providing direction for cGMPs to direct reports. Will 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.

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 related to the QA Supervisor position. Other duties may also be assigned.
• Responsible for supervising quality functions including in-process inspections and finished product inspections.
• Responsible for participating in customer audits at the discretion of management.
• Responsible for follow-up on all customer audits specific to the site including assisting in the audit response and monitoring commitments specific to the related areas.
• Participate in internal audits at Sharp facilities.
• Responsible for investigation of deviations related to procedures, policies, specifications or protocols.
• Participate in regulatory inspections at the local site at the discretion of Senior Management.
• Responsible for investigation of consumer complaints related to packaging that are received from customers.
• Review and revise SOPs on a designated basis to ensure accuracy.
• Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by Senior Management.
• Manage training of peers and subordinates.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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.

SUPERVISORY RESPONSIBILITIES:

Direct supervision of all quality assurance inspectors at the local site.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Associates or Bachelor’s degree is preferred; or two to four years of related experience and/or training; or a high school diploma degree with three to six related experience and/or training; or equivalent combination of education and experience. Experience in inspection of pharmaceutical or related industry is desired.

- Knowledge of FDA regulations related to cGMP’s is preferred.

- Thorough knowledge of quality control/assurance and/or operations is preferred.

- Good written and oral communication skills are required.

- Good organizational and planning skills are required.

- Able to communicate and interact effectively with others

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The working environment is clean and not normally subject to hazardous environment or conditions.