SUMMARY:

Responsibilities include both visual and physical inspection of packaging components and bulk products 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 minimum responsibilities related to the QA Incoming Inspector Level I position. Other duties may also be assigned.

• Assure that you are properly garbed prior to performing inspection according to the Sharp requirements.
• Verify all documentation (CoA, CoC, Bill of Lading, etc.) matches the material labeling and item specification.
• Responsible for the execution of the sampling and inspection of the components and bulk product assuring that they meet the item specification and documenting the results on the applicable inspection form.
• Operate a variety of testing equipment (FT-IR, Keyence, Magna-Mike, UV-Vis and Global Vision) and document the results on the applicable inspection form.
• Ability to use and read calipers and rulers.
• Work in electronics system for inventory, training and documentation storage.
• Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
• Responsible for training designated peers at management request. 
• Assist with receiving, transfer and shipping of controlled substances.

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:

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

• High School diploma, or equivalent

Preferred Skills/Abilities:

• Two (2) years of quality or manufacturing experience in a regulated environment

• Knowledge of cGMP (21CFR 210, 211, 820) and/or DEA regulations for controlled substances
• Knowledge of DEA regulations for controlled substances.
• Attention to detail.

• Strong communication skills (verbal and written), interpersonal skills, team building and organizational skills
• Ability to read, write and speak the English language and follow verbal and written instructions.
• Skill and ability to perform work in a thorough and accurate manner.
• Ability to use a wide variety of test and measurement equipment.
• Ability to follow and comply with procedures.
• Ability to develop and produce reports and documentation.
• Ability to work overtime (weekend – Saturday and/or Sundays)

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 employees frequently 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 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.  The ability to see color and assure it matches the specification is also a necessity.

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.

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.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.