Quality Auditor 2Nd Shift Jobs

L2 offers promotional opportunities - come grow with us!

Skills we're looking for include:

Ability to visually determine if product meets quality standards and an unwavering dedication to the qualify of the product produced;

Highly productive, organized and a strong team player;

Flexible and a positive attitude;

Commitment to the company’s vision, goals and its Core Values;

Quality Inspector Job Qualifications & Skills

Performs various sorting, inspection, production, and data entry

Quality Inspector Job Responsibilities & Duties

Reads and follows work instructions, work rules and directions

Maintains organization and cleanliness of work area

Uses inspection, measuring and test equipment as required

Fantastic team members who offer support and a fun atmosphere

Basic math, biology, and chemistry knowledge is required

Opportunities for advancement. We are growing!

Fishing contests and annual employee celebrations

Ensures and verifies that all plant departments and employees are adhering to the quality standards and guidelines of the company.

Actively monitors, teaches, and enforces plant sanitation policies, GMP’s, HACCP, and methods for allergen control

REQUIRED SKILLS, ABILITIES AND QUALIFICATIONS:

Perform random inspection activities at a frequency determined by Quality Management.

Identifies weaknesses within the manufacturing process and relays this information to management

Assist in corrective action root cause analysis when deemed necessary by Quality Manager.

Previous Quality Assurance inspection experience in a manufacturing and/or fabrication setting preferred.

Welding experience in pressure vessels a plus.

Maintains Quality Management System (QMS) programs and initiatives.

Experience of working in a high-volume digital print mail facility

Experience of working with teams in a collaborative environment

Must possess excellent communications skills (i.e., interpersonal, written, verbal and presentation)

Job responsibilities include, but not limited to:

Provides critical information for audits and reviews/analyzes data and documentation.

Quality Inspector Job Qualifications & Skills

Performs various sorting, inspection, production, and data entry

Quality Inspector Job Responsibilities & Duties

Reads and follows work instructions, work rules and directions

Maintains organization and cleanliness of work area

Uses inspection, measuring and test equipment as required

Quality Inspector Job Qualifications & Skills

Performs various sorting, inspection, production, and data entry

Quality Inspector Job Responsibilities & Duties

Reads and follows work instructions, work rules and directions

Maintains organization and cleanliness of work area

Uses inspection, measuring and test equipment as required

Use the inventory and traceability management systems to transact and research material.

Perform testing associated with product testing

Participate in and follow directions with regard to basic statistical analysis.

Assist engineers in failure analysis and CAPA activities.

Participate in continuous improvement projects.

Assist with quality issues and quality metrics-related activities.

Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently

Assist in the review of QC data and provide summaries to management as needed

Assist QC Management, as needed, in the completion of OOS, deviations, and CAPAs investigations for QC

Minimum 3-5 years’ experience in pharmaceutical industry environment or equivalent combination of education and experience

Perform or assist with QC method qualifications, transfers and validations

Experience working in cGMP or GLP pharmaceutical industry environment

Excellent organizational and project management skills and ability to handle multiple projects

Good organization and time management skills.

Working knowledge of FDA regulations, application of GMPs. Experience interacting with personnel from regulatory agencies.

Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.

Interact with FDA and other regulatory/audit groups. Working knowledge of FDA regulations and application of GMPs

Excellent writing and computer skills and ability to present data in a logical manner

Knowledge or experience in Parenteral manufacturing process

At least 2 years of overall work experience

Knowledge in documents such as safety rules, Standard Operating Procedures, Work instructions, investigations, validation reports, and protocols

Knowledge in current systems such as but not limited to SAP, Compliance Wire, Documentation System, Investigation System (Track Wise), LIMS

Certified Quality Auditor (CQA), Green Belt, Lean Manufacturing, and/or Kaizen certifications

Perform SAP transactions to ensure good Inventory practices of Parenteral Manufacturing Materials according to the established standards.

Participates in associate meetings and communicates any concerns to management.

Perform scheduled physical counts of inventory store in assigned locations.

Research and resolve inventory discrepancies involving products and quantities.

Accurately updates information on computer to maintain inventory records.

Represent the FEI organization to customers, associates and leadership as needed.

Develops and recommends improvements in warehouse practices to promote efficiency, faster service, and lower costs.

Must understand and apply cGMP requirements applicable to quality control laboratory.

Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results.

Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies.

Ensure that expired chemicals and reference standards are removed from laboratory area.

Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor.

Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Intermediate proficiency (Basic skills/knowledge. Capable of functioning independently) with Microsoft Word, Excel and PowerPoint

Experience in a quality discipline

Previous quality experience in a manufacturing environment

Experience with inspection and product auditing processes

Heavy equipment machine assembly experience with tractors or excavators

Physical Requirements (with or without reasonable accommodation):

Minimum of three (3) years of pharmaceutical laboratory experience is required with some demonstrated project management or leadership skills and/or experience

Five (5)+ years’ experience in a laboratory setting preferred with leadership and/or project management included, preferred.

Collaborates with direct reports to identify and enable their skill and knowledge development.

Share scientific knowledge for the evaluation of compendial changes

Must be proficient in computer applications including Microsoft Word, Access, Excel, and LIMS. Experience with SAP is preferred

Must have proven analytical investigation skills, as well as good written and oral communication

Computer skills including Word, Excel, and Internet experience.

Utilizes Visual Inspection Systems and other inspection tools (tensile strength machines/calipers/pin gages/etc.) per inspection requirements.

Previous minimum 4 years QA/QC experience with medical device manufacturer.

Experience in regulated environment (e.g. FDA QSR, ISO 13485, etc.).

Coordinates and delegates daily priorities to ensure accurate and timely completion.

Maintains accurate records for compliance with regulation.

Requires a high school education or equivalent.

12 to 18 months are required to achieve the job knowledge of all operations and documents pertaining to the specific job.

Basic office computer skills (such as Excel, Word, SAP, etc)

Assist the production department in quality improvement teams.

Assist production by detecting issues in supply depts prior to the entire coil being built and being sent to final inspection.

Understanding of how to conduct process audits.

1 to 2 years of experience in a manufacturing environment

Prior experience in quality and continuous improvement tools and techniques

Execution: Executes the assigned work per agreed work flows and in accordance with ABB standard processes and safety guidelines

Materials and output: Ensures availability of required materials to execute the assigned work per work flow.

Health & safety: Conducts shop floor operations in compliance with health & safety guidelines and reports any non-compliance

Perform other duties/projects as required

Knowledge of smart metering devices and power supplies

Ability to read basic production documents (I.e. work instructions, drawings), understand basic math skills and read measurement tools

A collaborative, solution-focused approach and strong written and spoken communication skills

Knowledge of basic electricity and circuits

Executing the assigned work according to specified workflows and in accordance with processes and safety guidelines

Physical pre-testing activities for newly developed products to ensure the quality of the product or manufacturing processes

Brings problems to the attention of the supervisor, manager, safety director or HR manager.

Minimum of 6 months of previous experience in a warehouse facility preferred.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physically check a percentage of all palletized incoming merchandise

Accurately count merchandise following predetermined procedures and methods.

Review case label information and verify contents by item, picks per case, etc…