Job Description Job Description
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.
