Quality Assurance Analyst

JOB SUMMARY:

The Quality Analyst is a meticulous and detail-oriented team member performing in the quality and regulatory areas. This role will be responsible for overseeing quality control processes under the quality director in both 503A and 503B compounding operations. The Quality Analyst will collaborate with various departments to identify areas for improvement, enhance quality, and ensure strict adherence to regulatory requirements.

QUALITY ASSURANCE:

· Perform comprehensive quality checks on compounded medications to guarantee they meet or exceed established quality standards for 503A and 503B operations.

· Employ Quality by Design principles to ensure product quality and consistency.

· Develop, review, and update Standard Operating Procedures (SOPs) related to quality control and compounding processes, in accordance with regulatory standards and process controls.

· Provide training and guidance to compounding staff on quality control processes, validation, qualification requirements, and adherence to SOPs, ensuring that 503A and 503B facilities align with best practices and regulatory requirements.

· Investigate quality-related incidents or concerns and collaborate with teams to identify root causes and implement corrective and preventative actions in both compounding settings, following established QMS procedures.

· Implement and monitor process controls to ensure the consistency and quality of compounded medications, continuously improving processes within the framework of the QMS.

ANALYSIS:

· Analyze data and reports to detect trends, anomalies, and potential areas for improvement in both compounding facilities.

· Utilize statistical techniques and process capability analysis.

· Evaluate compounding processes to identify inefficiencies and recommend enhancements that optimize product quality and operational efficiency for both 503A and 503B compounding, all within the framework of a robust Quality Management System (QMS).

· Generate regular quality performance reports for both 503A and 503B operations, presenting findings to management and relevant departments, and integrating them into the QMS for continuous improvement.

COMPLIANCE:

· Lead validation and qualification activities for equipment, processes, and systems within both compounding facilities, ensuring compliance with sBOP, USP, or cGMP requirements and industry best practices.

· Maintain accurate and up-to-date records of quality control tests, findings, validations, qualifications, and SOPs, ensuring compliance with regulatory requirements and QMS documentation standards.

· Ensure that both 503A and 503B facilities comply with all applicable industry regulations, including USP standards and cGMP, within the context of comprehensive QMS and process controls.

Performs other duties as requested by senior management

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SKILLS AND ABILITIES:

· Ability to work and communicate well with pharmacists, peers, and superiors in a cordial and professional manner.

· Excellent listening and communication skills

· Must be detail-oriented and inclined to make few mistakes.

· Committed to close follow-up and completion of all assigned tasks.

· Demonstrate teamwork and initiative.

· Ability to complete tasks promptly.

TECHNICAL SKILLS:

· Ability to understand Microsoft Office software, QS-1, Compounder

· Ability to operate basic office equipment such as copier, fax, telephone

EDUCATION: Bachelor’s degree

EXPERIENCE: Requires 5 to 7 years of quality experience

REQUIRED CERTIFICATES/REGISTRATIONS:

LANGUAGE SKILLS: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.

MATHEMATICAL SKILLS: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to maintain a level and appropriate business demeanor.

PHYSICAL CAPABILITIES: The physical capabilities 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.

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift

Ability to Relocate:

• Kennett Square, PA 19348: Relocate before starting work (Required)

Work Location: In person

Salary : $55,000