Quality Assurance Associate

The Ritedose Corporation; Columbia (SC); On-site; USD 30,000 - 43,000; Full time

Job summary

The Ritedose Corporation in Columbia, SC is seeking a QA Associate II to maintain training for QAA I and to review controlled documents in accordance with SOPs, CGMP, and regulatory requirements. The role focuses on batch record review, product labeling, and QA/QC activities to ensure compliance.

You will document review activities, track corrections, issue COA/CoC, and support manufacturing operations across packaging, dispensing, and utilities while upholding high integrity and attention to

Qualifications

• Proficient with word processing, spreadsheets, and databases.
• Strong written and verbal communication skills.
• Ability to work independently and in a team environment.

Responsibilities

• Batch record review for completeness, accuracy, and compliance to TRC standards.
• Verify critical processing steps and machine settings.
• Track corrections in batch records and issue COA/CoC.

Skills

Communication skills

Attention to detail

Independent with teamwork

Multitasking ability

Education

Associates degree

Bachelor's degree

3 years relevant experience

Tools

MS Office

Job description

Job Details: Job Location: The Ritedose Corporation - Columbia, SC 29203, Position Type: 5A, Salary Range: $26.60 - $26.60 Hourly, Job Shift: Day, Job Category: QA - Quality Control, The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents (both executed and unexecuted) in accordance with applicable SOPs. The QA Associate II will document review activities and status in the applicable Quality Systems. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, customer, and regulatory agency requirements.

Responsibilities:

• Batch record review for completeness, accuracy, and compliance to TRC standards
• Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
• Track the number of corrections made in batch records
• Issue product Certificate of Analysis or Conformance
• Review of QMS documentation for compliance to SOPs, Work Instructions, and CGMP requirements
• Manufacturing operations including supply chain, dispensing, compounding, filling, packaging, maintenance, and utilities
• Quality operations including process control, quality control, quality assurance, compliance, and audit
• Product labeling
• Track/trend the batch record review process- identify and initiate improvements to process
• Perform Product Complaint batch record review
• Maintain a professional team-oriented working relationship with fellow employees
• Follow written and verbal procedures as directed by Supervisor
• Follow TRC SOPs, safety and health guidelines and cGMP guidelines

Qualifications:

• Minimum of Associates degree with 1 year of relevant experience, Bachelors degree, or 3 years relevant experience
• Proficient with current word processing, spreadsheets, and database software
• A high level of integrity and attention to detail
• Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments
• Ability to handle and establish multiple priorities and meet expectations with minimal supervision
• Strong oral and written communication skills