QA Release Technician I

Jobtailor; Covington (OH); On-site; USD 40,000 - 68,000; Full time

Job summary

Jobtailor in Covington, Ohio, is seeking a Production Batch Records Specialist to ensure compliant manufacturing and accurate batch documentation. You will sample materials, log records, and coordinate disposition ahead of release, working within an FDA-regulated environment.

The role requires strong communication, problem-solving, and the ability to manage multiple deadlines while upholding cGMP and SOP standards.

Qualifications

• High School Diploma or GED required.
• Minimum of two years' experience in an FDA-regulated industry.
• Excellent oral and written communication skills.
• Strong interpersonal skills.
• Thorough understanding of equipment operation and manufacturing processes.
• Demonstrated strong analytical skills.
• Ability to work independently against multiple deadlines.
• Thorough knowledge of SOPs.
• Ability to provide clear direction and interpretation to staff.
• Demonstrated understanding of and ability to apply cGMPs.

Responsibilities

• Samples raw materials and assigns tests in LIMS according to approved SOPs.
• Coordinates disposition of the raw material prior to release for manufacturing use.
• Ensures that batches are manufactured according to approved SOP’s.
• Confirms batch, creates batch file, and logs the batch record.
• Manages batch records that are on an investigational, at risk, or hold status.
• Answers production questions and concerns regarding batch records.

Skills

Communication skills

Interpersonal skills

Analytical skills

SOP knowledge

cGMP knowledge

Deadline orientation

Independent work

Equipment operation

Batch record coordination

Education

High School Diploma or GED

Job description

Responsibilities

• Samples raw materials and assigns tests in LIMS according to approved SOPs
• Coordinates disposition of the raw material prior to release for manufacturing use
• Ensures that batches are manufactured according to approved SOP’s
• Confirms batch, creates batch file, and logs the batch record
• Manages batch records that are on an investigational, at risk, or hold status
• Answers production questions and concerns regarding batch records

Requirements

• High School Diploma or GED
• Minimum of two years' experience working in an FDA regulated industry
• Excellent oral and written communication skills
• Strong interpersonal skills
• Thorough understanding of equipment operation and manufacturing processes
• Demonstrated strong analytical skills
• Ability to work independently against multiple deadlines
• Thorough knowledge of SOPs
• Ability to provide clear direction and interpretation to staff
• Demonstrated understanding of and ability to apply cGMPs

Core Competencies

Demonstrates expertise in managing batch records and ensuring compliance with approved SOPs and cGMPs in an FDA regulated environment. Possesses strong analytical and communication skills to effectively coordinate production processes and address concerns.