Sr. Quality Assurance Associate

Avara Pharmaceutical Services; Norman (OK); On-site; USD 70,000 - 100,000; Full time

Job summary

Avara Pharmaceutical Services in Oklahoma is seeking a QA professional to review and approve batch records, deviations, and reports. You will administer the deviation and CAPA systems, internal and supplier audits, and provide GMP guidance across departments.

The role requires 3–5 years of GMP experience and strong QA background, with good communication and data-analysis skills. Expect collaboration with cross-functional teams and interaction with regulatory bodies.

Qualifications

• 3–5 years GMP experience in the pharmaceutical industry.
• 3–5 years direct QA experience.
• Strong verbal and written communication skills.
• Attention to detail and accurate record keeping.
• Able to multi-task and work independently with supervision as needed.
• Basic understanding of GMPs and CFR parts 210 & 211.
• Experience with statistics is preferred.

Responsibilities

• Review and approve batch records, deviation investigations, and related reports.
• Provide intradepartmental support in documentation for GMP-related activities.
• Administer deviation and CAPA systems, internal audits, and supplier audits.
• Provide GMP guidance to departments and project teams.
• Conduct internal and external audits; host audits by third parties and regulators.
• Review CAPA plans; ensure CAPA effectiveness and follow-up.
• Represent QA on site-wide, regional, and global project teams.
• Develop QA metrics and report results to management.
• Develop and administer QA training programs (GMP).
• Apply statistical tools and risk assessment methods to data.

Skills

GMP experience

QA experience

Communication skills

Attention to detail

Multi-tasking

Reading/writing English

Data analysis

Tools

Excel

Word

Job description

Review and approve batch records, deviation investigations, and reports. Provide inter- and

intradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities.

Administers the QA deviation and CAPA system, internal audit system, supplier audit system, and

all other necessary quality systems. Provides GMP guidance to other departments and project

teams.

• Assist in the investigation, reporting, and resolution of major deviations
• Review and approval of validation protocols and reports
• Review and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.
• Administration of the deviation and CAPA system
• Administration of the internal audit and supplier audit program
• Performance of internal and external audits
• Host and support for audits of APT by third parties, Avara corporate, and all regulatory bodies
• Review and approval of CAPA plans and completion
• Follow up on CAPA and deviation to ensure effectiveness
• Representation of QA on site-wide and regional and global project teams
• Provide GMP guidance to all affected departments at APT
• Development and preparation of all QA metrics and reporting the results to APT and regional and global management (Q10)
• Development and administration of APT OJT and GMP training program
• Use of statistical analysis tools to evaluate data
• Development and use of risk assessment tools

Quantitative Dimensions:

This position has direct impact on batch processing and release, disposition of materials and

components, approval and disposition of minor and major level deviations, the compliance state of

APT, and site wide project support. This position has direct interaction with international regulatory

agencies, APT suppliers and vendors, and other Avara affiliates and departments. This position has

an indirect impact on Avara-wide compliance and other company-wide projects.

Organizational Context:

• Reports to the Manager of Quality Assurance

Qualifications:

Required

• 3-5 years previous experience with GMP within the pharmaceutical industry
• 3-5 years direct QA experience
• Good verbal and written communication skills with basic computer skills.
• Attention to detail and accurate record keeping.
• Able to multi-task.
• Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standards
• Experience with statistical data analysis preferred
• Must be able to read, write and understand the English language (statement common to all Job Descriptions)
• Must be able to work independently with some supervision.
• Must be able to gather and evaluate data to make sound decisions.
• Must be able to exercise judgment in the resolution of problems.
• Office environment; must be able to sit at a desk for extended periods of time.
• Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes.
• Knowledge of CFR parts 210 &211
• Experience with Microsoft programs (Excel, Word, etc.)