Summary:

The Quality Assurance Inspector is trained and competent in assisting more experienced specialists in ensuring the implementation of the quality management system, the inspection of materials, conducting quality assurance audits, and monitoring and recording results of processes and procedures from manufacturing, production, and quality control activities. They continually assist in inspecting and comparing results to predetermined acceptance criteria and assist in taking corrective measures if any deviations are found in a team environment to ensure company processes are performed, and products are produced under current good manufacturing practices (GMPs), which comply with regulatory, company, and customer requirements.

Key Duties and Responsibilities:

Assists with performing quality reviews and approvals of manufacturing batch records/logbooks, production device history records/logbooks, and quality control testing records.
Assists more experienced specialists in performing quality reviews and approvals of new and updated documents.
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.
Assists with performing initial finished product inspections before releasing for sale.
Assists with monitoring in-process controls by performing line clearances and inspections to ensure compliance with process specifications.
Assists with performing in-process inspections.
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 creating certificates of analysis, certificates of sterilization, and certificates of product conformance.
Reviews the completion of manufacturing, production, and quality control records in accordance with good documentation practices (GDP), legibility, and accuracy before being scanned and archived.
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 supervisors with developing and updating incoming inspection specification documents in eQMS.
Assists specialists and supervisors with performing supplier corrective action reports, as needed.
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 accommodation 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:

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 Dutie:

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.