SUMMARY:

Responsibilities include both visual and physical inspection of packaging, components and bulk product related to contract packaging.  Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management.   

The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to inspection.  Other duties may also be assigned.

• Responsible for execution, documentation and release of the evaluation of incoming components related to the packaging processes.  This includes customer supplied, purchased and internally produced components.
• Responsible for sampling components and bulk products using the guidelines established in the standard operating procedures or item specifications.
• Responsible for the execution and documentation of required IR and Global Vision testing.
• Responsible for reviewing work of peers and releasing components at the discretion of QA management.
• Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
• Responsible for training of designated peers at management request. 

SUPERVISORY RESPONSIBILITIES:

None

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. 
• The individual must pass a colorblindness test to assure they can detect if a color is out of specification. 
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• Associate degree with two to four years related experience and/or training or Bachelor's degree is required with zero to two years related experience and/or training or a High School Degree with at least four years related experience and/or training.
• Experience in inspection of pharmaceutical or related industry is desired.  Outside certification of basic quality skills and practices (i.e. ASQ CQT, CQIA, CQI, etc.) is desired.

- General knowledge of FDA regulations related to cGMPs is desired.

- General knowledge of quality control/assurance is desired.

- Good documentation and communication skills are required.

- Good organizational and planning skills are required.

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations to assigned tasks.  This includes an understanding of statistical sampling plans.

LANGUAGE SKILLS:

Ability to effectively communicate (either written or verbally) with the following groups:

Internal: Daily contact with Quality, Warehouse, Materials Management and Account Management Departments for information on quality inspection issues and cGMP issues.

External: Frequent contact with customer representatives and/or material suppliers related to quality inspections.

REASONING ABILITY:

A thorough understanding of each aspect of the job is required.  Ability to make rational decisions pertaining to quality compliance.  Ability to resolve problems effectively and efficiently.

COMPUTER SKILLS:

Basic Windows applications including Microsoft Office Suite.  Experience with Lotus Notes and QAD desired.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee frequently will sit to complete paperwork.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor.  The working environment is clean and not normally subject to hazardous environment or conditions.

The noise level in the work environment is usually moderate.