Job Details

Summary: Performs independent inspection functions to verify product conforms to specifications. Monitors processes, provides support to Operations and enforces quality policies, procedures and programs.

Duties and Responsibilities:

· Performs and documents a wide variety of inspections, checks, tests and sampling procedures from incoming receipt to packaging and distribution

· Assists and support QA/QC Director in the oversight of QA activities and training

· Monitors all aspects of production to assure adherence to cGMP and SOPs

· Performs line clearance for removal of all previous products, components and foreign materials

· Performs first article and in-process inspections

· Communicates non-conformances to Supervisor and recommends corrective actions

· Reviews documentation to assure accuracy and completeness

· Performs reconciliation and closing of batch records

· Assists management in conducting inquiries and investigations

· Ensures timely release of finished goods

· Maintains quality records, reports, logs, and retention samples

· Coordinates destruction of expired records, documents and products

· Assists in preparation of customer and regulatory audits

· Performs other related duties as assigned by management

Work Experience/Qualifications:

· 2-3 years of relevant work experience required

· Experience in the Dietary Supplement or Pharmaceutical industry is desirable

· Working knowledge of cGMPs

· General proficiency in using Microsoft Word, Excel and Outlook

· Good verbal and written communication

· Good interpersonal skills

· Ability to work independently and in a team environment

· Ability to follow instructions

· Good attendance and punctuality

· Must be flexible and able to work overtime when required

· Good organizational skills/ attention to detail/ ability to work effectively in a fast-paced environment

Education Requirements:

· Minimum High School Diploma or equivalent

· ASQ CQA and/or CHA certification preferred

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 occasionally exposed to work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.

· The noise level in the work environment is usually moderate.

· While in the plant, the employee is required to utilize the required personal protective equipment.

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.

· Physical demands require sitting and walking for extended periods of time, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision and ability to adjust focus. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear.