In-Process Quality Coordinator - Pharmaceutical Associates, Inc

JOB DESCRIPTION
To provide customers a Quality product on a consistent basis. This is done by monitoring product quality and
providing QA support for Manufacturing activities on the production floor.

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.

1. Perform verification of manufacturing operations. This duty is performed daily, about 10% of the time.
2. Perform in-process testing (pH, specific gravity, etc.). This duty is performed daily, about 10% of the time.
3. Perform batch calculations. This duty is performed daily, about 20% of the time.
4. Perform QS verifications. This duty is performed daily, about 10% of the time.
5. Sample collection. This duty is performed daily, about 20% of the time.
6. Review and help revise SOPs and WIs. This duty is performed irregularly, about 5% of the time.
7. Data Entry Maintenance. This duty is performed daily, about 30% of the time.
8. Promote cGMP compliance in a FDA/DEA regulated pharmaceutical manufacturing Environment. This duty is performed daily, about 90% of the time.
9. Perform daily checks on the TOC levels. This duty is performed daily, about 5% of the time.
10. Perform Quarterly water reports. This duty is performed monthly, about 5% of the time.
11. Help to identify and present on-going initiatives for continuous improvements to the organizational's quality process. This duty is performed weekly, about 5% of the time.
12. Accountable for the compliance, accuracy and timeliness of responsibilities and work assigned. Also, accountable for personal honesty, integrity, good attendance, and strong work ethics.
13. 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.
14. Perform any other related duties as required or assigned.

QUALIFICATIONS
Experience in a cGMP environment. Familiar with general laboratory equipment.

EDUCATION AND EXPERIENCE
Must have an associates degree or higher in a specialized field, such as basic accounting, computer, etc., plus 2 years related experience. Or highschool diploma and equivalent combination of training
and experience.

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.

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

OTHER SKILLS
Detailed, critical thinking skills. Good communication skills – verbal and written. Intermediate math skills.

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