Production Quality Control Specialist Jobs

Knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.

Work with management and quality assurance in on-time closures of Deviations and LIRs.

4+ years of QC experience in the pharmaceutical laboratory industry

Lead laboratory investigations for OOS, OOE, OOTs and system suitability failures.

Lead deviation investigations related to QC laboratory, excursions, and adverse trends.

Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.

Computer literacy desired for recertification tracking and Lactec back-up requirements.

Minimum high school diploma and 3 years' experience in a quality, manufacturing and/or laboratory environment.

Responsible for quality inspections and the adjustment of Finished Goods and Intermediate batches during the manufacturing process.

Must review all adjustments to the final product with the Quality Specialist prior to can-out and shipment.

Make batch adjustments to production batches, as required by the Quality Specialist.

Perform Dirt Check Filtration process on Finished Goods as required by Customer

Release work orders and print travelers to support customer requirements.

Must have 3 years of experience working in a scheduling/production control environment

Knowledge basic Lean manufacturing principals such as 5S, Value Stream Mapping, and Process Improvement.

Mut have knowledge of tooling, fixtures, materials and processes

Update and maintain department metrics.

Proficient with Syteline and Factory Track; assists in day to day troubleshooting.

Aides to ensure that the quality system requirements are maintained.

Ensure quality assurance assessments at established supplier and client sites are performed in compliance with Company requirements

Manage and support issues in relation to scan docs.

Computer software skills including Microsoft Office, Word, Excel, Access, and Oracle (ERP) system.

Knowledge in API, ISO, and ASTM standards preferred

Review Source Documents including material test records to ensure quality, completeness, and accuracy to engineering specifications.

Assist in the management of sub-tier suppliers

Recommend process adjustments based on quality control data, visual inspection, and experience.

Help to manage and train of other technicians working in the quality process.

HSD required. Bachelor's degree and/or 3 to 5 years of equivalent training and/or experience preferred.

Works with guidance (but not constant supervision) to develop appropriate plans or perform necessary actions based on recommendations and requirements.

Excellent written and verbal communication skills.

Excellent interpersonal, verbal and written communication skills with strong technical writing experience.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Chemistry, Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.

Extensive knowledge of GLP and GDocP principles.

Capable of delivering to assigned work schedule with attention to detail and accuracy.

Support department risk assessments and participates in audit walk-throughs.

Experience in creating clear and concise documents (PowerPoint, memos, etc.) for educational purposes and statewide distribution.

At least 2 years of related experience in a hospital, regional or central cancer registry.

Bachelor’s degree in a health-related field, or substitute with four additional years of related experience.

Must maintain CTR credentials by attending either in-person or virtual educational meetings or other methods as prescribed by the NCRA.

Excellent knowledge of medical terminology, medical procedures, anatomy and physiology, and the cancer disease process.

Strong communication skills. Must have the ability to communicate accurately, concisely, and clearly.

Communicate statuses and completion of tasks to management

Knowledge of regulatory requirements, including FDA regulations and Good Manufacturing Practices (GMP) is preferred.

Calibrate, verify, and maintain laboratory equipment and coordinate associated maintenance, repairs & qualifications

Excellent communication skills, both verbal and written

Able to manage time and resources effectively, prioritize tasks, and work well both independently and with others

Able to manage a workload, prioritize tasks, and meet deadline

Experience in creating clear and concise documents (PowerPoint, memos, etc.) for educational purposes and statewide distribution.

At least 2 years of related experience in a hospital, regional or central cancer registry.

Bachelor’s degree in a health-related field, or substitute with four additional years of related experience.

Must maintain CTR credentials by attending either in-person or virtual educational meetings or other methods as prescribed by the NCRA.

Excellent knowledge of medical terminology, medical procedures, anatomy and physiology, and the cancer disease process.

Strong communication skills. Must have the ability to communicate accurately, concisely, and clearly.

At least one year of experience with colleague coaching and leadership through indirect or direct management positions.

Proven track record of strong communications, analytical, organizational, project management and planning skills.

Bachelor's Degree, or high school diploma with an additional 4 years of experience in lieu of Bachelor's Degree

Related professional certifications such as CAMS or CFE

Expanded knowledge of federal regulations (USA PATRIOT Act, Bank Secrecy Act, Federal Financial Institutions Examination Council etc.)

Excellent critical thinking, communication, interpersonal and organizational skills.

Skills / Knowledge - Acquires and applies job skills and learns company policies and procedures to complete assigned routine tasks.

Skills / Knowledge - Client polices, departmental procedures and applicable computer applications

What Are Our Desired Skills and Capabilities?

Must have 1-2 years of recent call center experience

This role has to the potential to be Work from Home after training is completed

Acts as a back-up to the customer service team as necessary to resolve customer account inquires during inbound customer service calls.

Responsible for QC sample and retain management

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)

Document and perform sample management related non-conformance investigations

A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry

Solid understanding of regulatory requirements, policies and guidelines

Experience with Quality Control document reviews and regulatory inspection processes

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Generous paid time off, including:

Job Requirements; Knowledge, Skills, Abilities, and Accountability:

Bachelor’s degree; or combination of education and experience.

Minimum 5 years’ successful experience in college financial aid in post-secondary educational environment.

Wide knowledge of regulatory requirements (e.g., federal, state, etc.) related to Title IV student financial aid.

Basic knowledge of CampusVue database (preferred)

Vice President of Financial Aid

Report OOT/OOS results and other deviations to area management and help remediate issues

Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections

Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements

Typically requires 4+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Participate in executing and/or review of method validations, method transfers and/or equipment qualification/requalification

The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential

Perform data entry and analysis as required to maintain production logs or other data capture tools.

Document process deviations in EtQ system and report to the Quality Control Manager.

Must meet/comply with all safety requirements, attend required training and wear personal protective equipment where required.

Minimum of 2 years experience

Demonstrated written and oral communication skills

Experience in the beverage or food industry

Bachelor or Master degree in Comp. Science, Engineering or other relevant technical field, or equivalent combination of work experience and education

Solid knowledge of networking, routing, switching, firewalls, routers, etc.

Previous hands on experience in identifying product failure modes and conducting root cause analysis is required.

Previous experience of using scripting tools (e.g. pl, Python, etc.) for product quality data analysis is a plus.

Previous experience of participating in ISO audit is a plus.

Excellent verbal and written communications and people skills.

Ability to communicate successfully with all levels of employee and management.

Qualifications: Requirements - Required and/or Preferred

Collect/compile daily production qty and quality control data. The data collected/compiled shall be informed to managers as daily/ weekly/monthly periodic reports.

Knowledgeable on quality control of the Assembly production process.

Knowledgeable on control contamination of Assembly production process.

Understanding of battery manufacturing control, daily output/quality control/contamination eliminate process, and experience.

2+ years of experience in a production-related field such as Manufacturing, Quality, Production Engineering, Supplier Management, and/or Supplier Quality

Review and validation of product non-conformances and disposition type, quality procedures and engineering requirements.

2+ years of experience with conducting quality investigations, Root Cause analysis and implementation and verification of Corrective Actions in production environments

2+ years of experience using all the following Microsoft Office Applications (Word, Excel and Outlook)

2+ years’ experience developing presentations for senior leadership

Experience working directly with suppliers.

Required Skills, Knowledge & Abilities:

Essential Job Duties & Responsibilities:

Assist the Quality Control Manager with projects from time-to-time

Communicate loan detail findings and resolutions with the Underwriting Manager as quickly as possible

3 years compliance and/or underwriting experience in the retail mortgage lending industry

Strong working knowledge of federal, state, and regulatory rules, laws, regulations, underwriting guidelines and statutes relevant to the mortgage industry