Job Overview
Compensation
Hourly
Range $17.25 - $23.25
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Professional Development
Disability insurance
Employee assistance program
Job Description
The hiring establishment is a pharmaceutical manufacturing company with operations located in Port Allen, Louisiana, and a secondary facility in Coppell, Texas. This company specializes in the production and processing of active pharmaceutical ingredients (APIs), drug products, and medical devices. As a trusted entity within the pharmaceutical industry, the company adheres to stringent regulatory requirements governed by agencies such as the FDA (Food and Drug Administration), OSHA (Occupational Safety and Health Administration), EPA (Environmental Protection Agency), and enforces current Good Manufacturing Practices (cGMPs) to ensure the safety, efficacy, and quality of their products. The company places immense importance on quality integrity throughout every stage of manufacturing, processing, and packaging, thereby safeguarding patients’ health and upholding customer satisfaction.
The role being offered is a Quality Technician - Intermediate, a critical position responsible for conducting quality control inspections and analytical assessments within manufacturing and laboratory environments. This role suits an individual who is passionate about maintaining high standards of product quality and compliance within a regulated pharmaceutical environment. The position requires approximately 18 months of experience and entails active participation in validating that manufacturing activities comply rigorously with cGMPs and other relevant quality standards.
The Quality Technician’s duties may vary depending on the starting assignment — either within the incoming laboratory and in-process inspections track or within the analytical laboratory track. For those situated in laboratory and in-process inspections, responsibilities include performing area and line clearances, carrying out in-process inspections, ensuring proper control of components and products during manufacturing, and monitoring process performance metrics against established standards using statistical process control (SPC) and statistical quality control (SQC) techniques. Inspecting labels for accuracy and assisting in production schedule planning are also important facets of this role. Moreover, the technician supports quality audits, investigates nonconformance events, and helps develop corrective and preventive measures.
On the other hand, technicians starting in the analytical laboratory setting are tasked with performing precise chemical analyses of raw materials, in-process materials, finished products, and samples related to drug stability and research and development projects. Their duties include the safe handling and documentation of chemicals and reagents, instrument calibration and maintenance, review of work performed by other analysts, and maintaining an organized and compliant laboratory environment. Both role variants require teamwork, attention to detail, and a commitment to regulatory compliance and quality assurance principles.
The position requires at minimum an associate’s degree in a technical or scientific field, with a preference for candidates possessing a bachelor’s degree, ideally in a science-related discipline. Prior experience within a regulated manufacturing environment is highly desirable, as is certification in quality management or engineering (such as ASQ CQE or CQA).
Essential competencies for the role include a solid understanding of drug cGMPs, OSHA, EPA, and FDA regulations, proficiency with Microsoft Word and Excel for documentation, strong mathematical and mechanical aptitude, as well as excellent interpersonal, communication, and organizational skills. The candidate must demonstrate an assertive and collaborative nature, upholding policies and procedures while maintaining a team-oriented approach. A basic knowledge of laboratory analyzers and inspection instruments used for chemical and component assessments rounds out the core skill set.
The role being offered is a Quality Technician - Intermediate, a critical position responsible for conducting quality control inspections and analytical assessments within manufacturing and laboratory environments. This role suits an individual who is passionate about maintaining high standards of product quality and compliance within a regulated pharmaceutical environment. The position requires approximately 18 months of experience and entails active participation in validating that manufacturing activities comply rigorously with cGMPs and other relevant quality standards.
The Quality Technician’s duties may vary depending on the starting assignment — either within the incoming laboratory and in-process inspections track or within the analytical laboratory track. For those situated in laboratory and in-process inspections, responsibilities include performing area and line clearances, carrying out in-process inspections, ensuring proper control of components and products during manufacturing, and monitoring process performance metrics against established standards using statistical process control (SPC) and statistical quality control (SQC) techniques. Inspecting labels for accuracy and assisting in production schedule planning are also important facets of this role. Moreover, the technician supports quality audits, investigates nonconformance events, and helps develop corrective and preventive measures.
On the other hand, technicians starting in the analytical laboratory setting are tasked with performing precise chemical analyses of raw materials, in-process materials, finished products, and samples related to drug stability and research and development projects. Their duties include the safe handling and documentation of chemicals and reagents, instrument calibration and maintenance, review of work performed by other analysts, and maintaining an organized and compliant laboratory environment. Both role variants require teamwork, attention to detail, and a commitment to regulatory compliance and quality assurance principles.
The position requires at minimum an associate’s degree in a technical or scientific field, with a preference for candidates possessing a bachelor’s degree, ideally in a science-related discipline. Prior experience within a regulated manufacturing environment is highly desirable, as is certification in quality management or engineering (such as ASQ CQE or CQA).
Essential competencies for the role include a solid understanding of drug cGMPs, OSHA, EPA, and FDA regulations, proficiency with Microsoft Word and Excel for documentation, strong mathematical and mechanical aptitude, as well as excellent interpersonal, communication, and organizational skills. The candidate must demonstrate an assertive and collaborative nature, upholding policies and procedures while maintaining a team-oriented approach. A basic knowledge of laboratory analyzers and inspection instruments used for chemical and component assessments rounds out the core skill set.
Job Requirements
- Associate's degree in technical or scientific related field
- minimum 18 months of experience
- knowledge of drug cGMPs, OSHA, EPA, and FDA regulations
- proficiency in Word and Excel
- strong mathematical skills
- mechanical aptitude
- excellent communication and interpersonal skills
- detail-oriented approach
- ability to collaborate effectively within teams
- assertiveness in enforcing compliance
- basic understanding of laboratory equipment used in analyses
Job Qualifications
- Associate's degree in technical or scientific related field
- bachelor's degree preferred
- experience in regulated work environment preferred
- quality certificate preferred (such as ASQ CQE, CQA)
- proficiency in Word and Excel
- strong mathematical skills
- good mechanical aptitude
- excellent oral and written communication skills
- strong interpersonal and organizational skills
- attention to detail
- team-oriented work ethic
- collaborative and tactful communication skills
- assertive in enforcing regulations and policies
- basic knowledge of laboratory analyzers and inspection equipment
Job Duties
- Performs area clearances/line clearances
- performs in-process inspections of manufacturing processes
- inspects and disposes of incoming material
- monitors manufacturing process performance related to SPC/SQC
- ensures general compliance of manufacturing and warehouse areas
- controls non-compliant components, products, or equipment
- prepares and attaches material quality status labeling
- verifies all labels after final printing
- executes assigned activities per production schedule
- assists in quality procedure development and maintenance
- supports quality audits through investigations and corrective actions
- performs product quality assurance tasks
- conducts special projects assigned by supervisor
- performs chemical analysis of raw materials and products
- collects and documents raw materials and chemical reagents
- calibrates and maintains analytical instruments
- reviews analysts' work
- performs routine housekeeping in laboratory
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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