Batch Release Coordinator

Summary:

The Batch Release Coordinator maintains quality standards by reviewing manufacturing and production batch records for accuracy, completion, and acceptability before approving products for sale or distribution. The Batch Release Coordinator must have a sharp eye for errors, strong problem-solving skills, and can work well under pressure. Batch records are reviewed for accuracy, and completion in accordance with Good Documentation Practices (GDP). Batch records that are identified as being nonconforming are identified and addressed through the quality management system. The Batch Release Coordinator works with the Quality Assurance Team under minimal supervision.

Key Duties and Responsibilities:

• Collaborate with customer service, manufacturing, production, and shipping departments to ensure the release of products manufactured by Chemence Medical Inc. comply with quality standards and established timeframes required to meet company objectives.
• Performs quality reviews and approvals of manufacturing batch records/logbooks, production device history records/logbooks, and quality control testing records.
• Creating and revising Certificates of Analysis for finished goods, pre-shipment samples, etc.
• Reviews the completion of manufacturing, production, and quality control records in accordance with GDP, legibility, and accuracy before being scanned and archived.
• Secondary in helping manage the calibration of company equipment with approved service suppliers ensuring all activities are performed in accordance with contracted requirements and company procedures, ensuring all certificates and reports are processed, and that equipment schedules are updated and maintained.
• Assists with performing GMP walk-through inspections of assigned departments to ensure compliance with cGMPs, regulatory requirements, company policies and procedures, occupational health, safety, and environmental standards.
• Perform line clearances and inspections as needed to ensure compliance with process specifications.
• Assists during surveillance and re-certification ISO audits, as needed.
• Supports both internal and external CAPA-related auditing activities, as needed.
• Acts as the first responder for on-the-floor quality issues promptly and assists with the documentation of events/investigations and required immediate corrective actions.
• Participates in root cause analysis activities using methodologies, such as fishbone, 5 whys, comparative analysis, etc.
• Assists with performing acceptable quality limit (AQL) inspections on incoming materials using calibrated inspection, measuring, and test equipment.
• Assists with the review and approval of environmental and product bioburden records.
• Assists with the review and approval of manufacturing and production environmental records.
• Assists specialists and supervision with developing and updating incoming inspection specification documents in eQMS.
• Assists with creating purchase requisitions for quality testing activities, supplies, and miscellaneous standards.
• Interprets, applies, and complies with quality assurance standards, procedures, and policies.

Qualifications, Education, and/or Experience Required:

• Familiarity with cGMPs, FDA 21 CFR Parts 11, 801, and 820
• Familiarity with ISO 13485:2016
• Familiarity with ISO 14971:2019
• Critical/logical thinking to not only identify problems, but also be able to help provide novel solutions to ensure efficiency and quality of the manufacturing process.
• Attention to detail being able to spot when processes don’t comply with requirements.
• The ability to be able to read, interpret, and apply the details of external guidance and industry regulations.
• Analytical skills to gather and interpret data, be able to spot trends, and notice outliers.
• High school diploma/GED
• 6 to 12 months of previous experience in quality assurance or a similar field.
• Associate Degree preferred.
• Basic understanding of statistical tools, improvement methods, and concepts of quality assurance.
• Excellent communication skills, both verbal and written.
• Basic skill, knowledge, and ability with the use of Microsoft Office Software

Language Skills:

• English required, bilingual (Spanish) a plus.
• Reasonable accommodations can be made, up to and including translation services.

Physical Demands:

• Must be able to wear appropriate PPE
• Able to sit, stand and walk around for long hours at a time
• Ability to Lift 20 lbs. routinely
• Ability to crouch, bend, twist, and reach
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions

Work Environment:

• Temperature-controlled office and laboratory, non-temperature controlled warehouse
• Must be able to work in an environment with variable noise levels
• Must be able to work in a manufacturing setting with exposure to various product-related chemicals
• Ability to work in variable temperatures (Warehouse and walk-in refrigeration)

Other Duties:

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• Employees holding this position will be required to perform any other job-related duties as requested by Management.

AAP/EEO Statement:

CHEMENCE® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 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.