In-Process Quality Coordinator Iii (1St Shift M-F)

GENERAL DESCRIPTION OF POSITION

This position is responsible for the implementation of PAI specifications in the SAP system (metadata) and Quality system and perform inspection testing of incoming Contract Manufacturer product. The position is a liaison with the warehouse, customer service and manufacturing for incoming goods. Inspection to quality standards of contractor records, temperature data and goods received against specification for commercial distribution. This position supports the Addiction Treatment Program

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Set up metadata in SAP of new drug products and establish workflows for inspection criteria in the documentation quality system.
2. Work with contract manufacturer for required data to support the receipt and inspection of contract product.

1. Sample and inspect incoming drug products and/or components against quality standards. Record and review documentation for accuracy and completeness.

1. Develop inspection criteria for contract products to include label review, temperature requirements, and destructive testing for quality attributes.
2. Track contract supplier performance and quality agreements
3. Disposition product after inspections
4. Maintain all working areas in a clean and orderly state. Assure products are stored, segregated and clearly labeled.
5. Performs inventory reconciliations and report discrepancies immediately to the Supervisor.
6. Perform other related duties as required or assigned.
7. Support Addiction Treatment Program initiatives through continuous improvement
8. Manage change controls, deviations, supplier action reports for contract products within PAI quality system as required.

QUALIFICATIONS

To perform this job, the individual must have a FDA 21Part210/211 knowledge. Quality inspection experience. Technical writing ability. Computer experience, SAP experience preferred. Advance knowledge of Microsoft platform is requirement.

EDUCATION AND EXPERIENCE

Knowledge of quality assurance in the drug industry with emphasis on contract manufacture requirements. Must have experience in inspection techniques, knowledge of batch records, certificates of compliance and assurance. Must pay attention to detail and perform inspections according to defined specification.

Understand computer entry of meta data for setting up workflows in SAP.

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 non- supervisory 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 calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts such as fractions, ratios, and proportions to practical situations.

CRITICAL THINKING SKILLS

Ability to utilize common sense understanding in order to carry out written, oral or diagrammed instructions. Ability to deal with problems involving several known variables in situations of a routine nature.

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 regarding general 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 also frequent opportunity for decision-making of major importance; the latter of which would affect the work operations of other employees and/or clientele to a moderate degree.

MENTAL DEMAND

Moderate mental demand. Operations requiring almost continuous attention, but work is sufficiently repetitive that a habit cycle is formed; operations requiring intermittent directed thinking to determine or select materials, equipment or operations where variable sequences may be selected by the employee.

ANALYTICAL ABILITY / PROBLEM SOLVING

Moderately structured. Fairly broad activities using moderately structured procedures with only generally guided supervision. Interpolation of learned things in somewhat varied situations.

USE OF MACHINES, EQUIPMENT AND/OR COMPUTERS

Regular use of complex machines and equipment (desktop/laptop computer and software, road and production machines and equipment, etc.)

ACCURACY

Probable errors of internal and external scope would have a moderate effect on the operational efficiency of the organizational component concerned. Errors might possibly go undetected for a considerable period, thereby creating an inaccurate picture of an existing situation. Could cause further errors, losses, or embarrassment to the organization. The possibility for error is always present due to the requirements of the job.

PUBLIC CONTACT

No public contact.

EMPLOYEE CONTACT

Not indicated.

REQUIRED CERTIFICATES, LICENSES, REGISTRATIONS

Not indicated.

PREFERRED CERTIFICATES, LICENSES, REGISTRATIONS

Not indicated.

SOFTWARE SKILLS REQUIRED

Intermediate: Database, Spreadsheet, Word Processing/Typing

Basic: Alphanumeric Data Entry, Other, Payroll Systems, Presentation/PowerPoint

ADDITIONAL SOFTWARE SKILLS

Not indicated.

OTHER SKILLS

Detailed, critical thinking skills. Good communication skills – verbal and written. Intermediate math skills. Experience in a cGMP environment preferred. Familiar with general laboratory equipment.

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 accommodation 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; frequently required to climb or balance; and occasionally required to sit, use hands to finger, handle, or feel, reach with hands and arms.

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 regularly exposed to work near moving mechanical parts; occasionally exposed to toxic or caustic chemicals.

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.

EEO Employer / Veteran / Disabled

More ADDITIONAL INFORMATION

Gowning requirements.