Quality Assurance Tech II

Paladin Labs Inc.; St. Louis, Northern (MO, KY); Hybrid; USD 52,000 - 76,000; Full time

Job summary

Par Health is seeking a Quality Assurance Technician II to perform batch record review and resolve documentation issues in manufacturing. You will participate in inspections of returned goods and ensure cGMP compliance, working with production and quality teams in a predominantly office environment with some manufacturing exposure.

The role requires 1–3 years of document review experience in a cGMP setting, proficiency in MS Word/Excel, and knowledge of FDA regulations.

Qualifications

• HS Diploma required; further degree preferred.
• 1–3 years of document review in a cGMP environment preferred.
• Proficient with MS Word and Excel.
• Knowledge of FDA and cGMP regulations preferred.
• Experience with LIMS, BPCS and TrackWise preferred.

Responsibilities

• Execute batch record review and document deficiencies in a computerized system.
• Identify and report exceptions to production.
• Resolve documentation discrepancies with manufacturing operations for material release.
• Perform batch record accountability and box reconciliation.
• Execute line clearances and assist in inspection of returned goods.
• Follow cGMP guidelines for pharmaceutical operations.
• Conduct GMP walkthroughs with production.
• Participate in cross-functional teams to improve review efficiency.
• Maintain 100% safety training completion and Compliance Wire training.

Skills

Attention to detail

Communication skills

Reading comprehension

Education

HS Diploma

Associates or Bachelor's degree preferred

Tools

MS Word

MS Excel

LIMS

BPCS

TrackWise

Job description

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

Job Description Summary

The Quality Assurance Technician II performs a variety of review processes with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is also responsible for return good inspections, cGMP area inspections and product inspections. This role ensures QA compliance and that cGMP principles are adhered to.

ESSENTIAL FUNCTIONS:

• Execute batch record review and document deficiencies in a computerized system
• Identify exceptions and report exceptions to production
• Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
• Perform batch record accountability and Iron Mountain box reconciliation
• Execute line clearances and assist in inspection of returned goods
• Follow all internal and basic cGMP guidelines for pharmaceutical operations
• Perform GMP walkthroughs with production on a routine basis
• Participate in cross-functional teams to improve review efficiency and support
• Adhere to all safety rules and maintain 100% completion of all safety required training
• Maintain 100% on time Compliance Wire training

MINIMUM REQUIREMENTS:

• Education: HS Diploma is required; Associates or Bachelor's degree is preferred.
• Experience: Minimum of 1-3 years of document review experience in a cGMP environment preferred.
• Proficiency in MS Word and Excel.
• Proven knowledge of FDA and cGMP regulations preferred.
• LIMS, BPCS, and TrackWise experience preferred.

Preferred Skills/Qualifications:

• Ability to communicate at a high level of written and oral skills
• Ability to read and comprehend complex calculations and formulas
• Ability to focus and review batch records for an extended period of time
• Knowledge of cGMPs for APIs
• Ability to quickly identify, communicate and/or resolve issues
• Ability to read and understand complex batch records
• Ability to keep batch records organized and easily retrievable at all times
• Excellent verbal and written communication skills
• Ability to understand and apply good documentation practices
• Ability to build relationships with partners

COMPETENCIES:

• Organizing
• Peer Relationships
• Functional/Technical Skill
• Time Management
• Priority Setting
• Attention to Detail

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to Quality Supervisor. Works with Manufacturing and Quality personnel on a daily basis

WORKING CONDITIONS:

85 % Office environment which includes sitting for long periods of time and computer use. 15 % Manufacturing environment exposure including temperature, noise, or chemical exposure.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills require

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Come join us!

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.