Quality Assurance Inspector 1st Shift

GENERAL DESCRIPTION
To provide customers a Quality product on a consistent basis. This is done by monitoring product quality
routinely with various visual and physical inspections to assure it meets our Quality Standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES
This position is considered full time, 40-hour per week on average, position on a daily basis. Follows
all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions. This duty is
performed daily, about 100% of the time.

• Promote cGMP compliance in a FDA/DEA regulated pharmaceutical manufacturing Environment. This duty is performed daily, about 100% of the time.
• Perform inspections throughout the packaging process on in-process samples as well as finished products ready for release. This duty is performed daily, about 60% of the time.
• Perform inspections of the packaging rooms and the packaging lines for clearance purposes. This duty is performed daily, about 20% of the time.
• Record data and review documentation for cGMP compliance and accuracy. This duty is performed daily, about 20% of the time.
• Develop a working knowledge of statistical based sampling plans. This duty is performed annually, about 5% of the time.
• Continuously develop a working knowledge of cGMPs, SOPs, WIs, and FDA regulations. This duty is performed annually, about 5% of the time.
• Segregate, quarantine, document, and investigate non-conforming material incidents. This duty is performed irregularly, about 5% of the time.
• Initiate, document, and oversee Process Issues. This duty is performed irregularly, about 10% of the time.
• Help to identify and present on-going initiatives for continuous improvements to the organization's quality process. This duty is performed irregularly, about 5% of the time.
• Perform in-line inspection equipment challenges. This duty is performed daily, about 5% of the time.
• Calibrate and program in-line and off-line scales and document calibration. This duty is performed daily, about 5% of the time.
• Help train new QA inspectors if needed. This duty is performed irregularly, about 5% of the time.
• Accountable for the compliance, accuracy and timeliness of responsibilities and work assigned. Also accountable for personal honesty, integrity, good attendance, and strong work ethics.
• Maintain skill set by remaining current in industry standards and best practices through continuous training. This duty is performed daily, about 100% of the time.
• Perform any other related duties as required or assigned.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty mentioned
satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability
required.

EDUCATION AND EXPERIENCE
High school, plus specialized schooling and/or on the job education in a specific skill area; E.G. data
processing, clerical/administrative, equipment operation, etc, plus 12 to 18 months related experience and/or
training. Or equivalent combination of education and experience.

COMMUNICATION SKILLS
Ability to read and understand simple instructions, short correspondence, notes, letters and memos; Ability to
write simple correspondence.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply and divide numbers. Ability to perform these mathematical skills using
money and other forms of measurement.

CRITICAL THINKING SKILLS
Ability to use common sense understanding in order to carry out simple multi-step instructions. Ability to
deal with standardized situations with limited variables.

SOFTWARE SKILLS REQUIRED
Basic: Alphanumeric Data Entry, Database, Other, Payroll Systems, Spreadsheet, Word Processing/Typing

OTHER SKILLS
Ability to perform the physical tasks associated with the listed job. Must be organized, reliable and detailed
oriented. Needs to be able to multi-task and prioritize effectively. Familiar with operating a barcode scanner,
torque meter, vacuum desiccator, checkweigher, scale / balance, and a scientific calculator.

ADDITIONAL INFORMATION
To perform this job successfully, an individual must be able to perform the essential job functions
satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities
Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages
both prospective and current employees to discuss potential accommodations with the employer.

PAI uses E-Verify.
EEO Employer / Veteran / Disabled