GENERAL DESCRIPTION OF POSITION

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.

RESPONSIBILITY FOR FUNDS, PROPERTY and EQUIPMENT

None.

SUPERVISORY RESPONSIBILITIES

Directly supervises 0 subordinate supervisor(s) who supervise(s) a total of 0 employee(s). Supervises 0 nonsupervisory

employee(s). Carries out supervisory responsibilities in accordance with the organizations

policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning,

assigning and directing work; appraising performance, rewarding and disciplining employees; addressing

complaints and resolving problems.

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.

SUPERVISION RECEIVED

Under general supervision where standard practice enables the employee to proceed alone on routine work,

referring all questionable cases to supervisor.

PLANNING

Limited responsibility with regard to specific assignments in planning time, method, manner, and/or sequence

of performance of own work operations.

DECISION MAKING

Performs work operations which permit frequent opportunity for decision-making of minor importance and

which would not only affect the operating efficiency of the individual involved, but would also affect the

work operations of other employees and/or clientele to a slight degree.

MENTAL DEMAND

Light mental demand. Operations requiring intermittent directed thinking to carry out predetermined

procedure or sequence of operations of limited variability. Operations requiring intermittent attention to

control machine or manual motions.

ANALYTICAL ABILITY / PROBLEM SOLVING

Repetitive. Activities or duties using a pre-determined set of processes or directions coupled with nearby

supervision. Learned things in situations where choice is simple or patterned.

ACCURACY

Probable errors of internal scope readily detected in normal course of work by standard check or routine

crosscheck within a single department or office. Errors resulting from inaccuracy would create minor

confusion, delay or expense to correct the situation.

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.

PHYSICAL ACTIVITIES

The following physical activities 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 and expectations.

While performing the functions of this job, the employee is continuously required to stand, walk, talk or hear;

occasionally required to sit, use hands to finger, handle, or feel, reach with hands and arms, stoop, kneel,

crouch, or crawl.

The employee must occasionally lift and/or move up to 50 pounds, frequently lift and/or move up to 25

pounds, continuously lift and/or move up to 10 pounds. Specific vision abilities required by this job include

close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

ENVIRONMENTAL CONDITIONS

The following work environment characteristics described here are representative of those an employee

encounters while performing essential functions of this job. Reasonable accommodations may be made to

enable individuals with disabilities to perform the essential functions.

While performing the functions of this job, the employee is occasionally exposed to work near moving

mechanical parts.

The noise level in the work environment is usually moderate.

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.