Quality Control Analyst
2 weeks ago
Position Overview:
1st Shift
Summary: This role is integral to the Manufacturing operations.
This position entails a thorough review of manufacturing documentation. The primary responsibility is to assess batch records and other GMP documents to ensure adherence to cGMP standards, company policies, and local SOPs.
Key Responsibilities:
• Facilitate the review of batch documentation for manufacturing.
• Ensure that manufacturing batch records align with specifications and are submitted to Quality in accordance with the release schedule.
• Verify that batch documentation meets GDP standards.
• Evaluate acceptability based on specifications and standard operating procedures.
• Confirm the presence of all necessary documentation before submitting the batch folder to Quality.
• Organize files to ensure documents are easily accessible and retrievable.
• Initiate and complete GME work orders.
• Draft Non-Conformance Records (NCRs) and conduct Exception Investigations.
• Prepare TCU documentation changes, including revisions, periodic reviews, and GAP assessments.
• Utilize the Maximo system to generate department preventative maintenance work orders; assign and complete as required.
• Employ SYSTECH to review and approve batch counts.
• Initiate batch folders through necessary data entry.
• Assist with GME cycle counting as necessary.
• Perform other administrative tasks as assigned.
Qualifications:
To excel in this role, candidates must demonstrate the ability to fulfill each essential duty effectively.
Required Skills and Abilities:
• Proficient in MS Office Suite.
• Familiarity with documentation systems and batch/systems documentation is preferred.
• Exceptional attention to detail.
• Ability to work independently in a dynamic environment while adhering to written procedures. Must be organized and capable of prioritizing tasks.
• Strong verbal and written communication skills across all organizational levels.
• Identify opportunities for continuous improvement.
• Willingness to adjust work hours and work overtime based on business needs.
• Capability to lift up to 30 pounds.
• No allergies to Penicillin or Cephalosporin drugs.
Education and Experience:
• An Associate's degree or a minimum of 3 years of experience in a manufacturing environment and/or quality documentation is required.
-
Laboratory Quality Control Associate
2 weeks ago
Round Lake, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition Title: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 ten-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for the 40 hours)Role Summary:The Quality Lab Associate I role involves conducting biological, chemical, and physical evaluations of...
-
Quality Control Chemist
2 weeks ago
Round Lake Beach, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition: Quality Control ChemistCompany: DivIHN Integration IncLocation: Round Lake, ILDuration: 12 MonthsImportant Note: Candidates must not have allergies to Penicillin, Cephalosporin, or related substances.Role Summary:The Quality Control Chemist will be responsible for conducting analytical evaluations, validation, and transfer of testing...
-
Quality Analyst
2 months ago
Round Lake Beach, Illinois, United States Takeda Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Quality Assurance Analyst II
2 weeks ago
Lake Bluff, Illinois, United States Experis Full timeCompany Overview:Experis IT ManpowerGroup is collaborating with a prominentMedical Device Companyto fill a critical role in their quality assurance team.Position:Quality Assurance Analyst IILocation:OnsiteContract Duration:12 monthsWorking Hours:Monday to Friday, 8 am - 4 pmCompensation:$28 per hourRole Responsibilities:As a Quality Assurance Analyst, you...
-
Quality Assurance Analyst II
1 week ago
Lake Bluff, Illinois, United States Experis Full timePosition Overview:We are seeking a dedicated Quality Assurance Analyst to join our team. This role is essential in ensuring the quality of products and processes in compliance with established operating procedures and industry standards.Key Responsibilities:Conduct thorough analyses of verbal and statistical data to generate comprehensive reports and studies...
-
Quality Control Technician
7 days ago
Crystal Lake, Illinois, United States Technipaq Full timeJob SummaryThe Quality Inspector plays a crucial role in ensuring the highest standards of quality in our manufacturing processes. As a key member of our quality team, you will be responsible for performing routine checks, tests, and inspections to guarantee that our products meet customer specifications and quality guidelines.Key ResponsibilitiesConduct...
-
CAPA Process Analyst
6 days ago
Lake Forest, Illinois, United States GTT, LLC Full timeJob SummaryWe are seeking a highly skilled CAPA Process Analyst to join our team at GTT, LLC. As a key member of our quality assurance team, you will be responsible for leading investigations and implementing corrective actions to ensure compliance with regulatory requirements.Key ResponsibilitiesInvestigation and Root Cause Analysis: Lead complex and...
-
Quality Assurance Specialist II
2 weeks ago
Round Lake, Illinois, United States Mindlance Full timePOSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer II. KEY RESPONSIBILITIES:This role is primarily accountable for the investigation, evaluation, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality system inputs. Assess individual...
-
Quality Assurance Specialist II
2 weeks ago
Round Lake, Illinois, United States Mindlance Full timePOSITION SUMMARY:This document outlines the qualifications and responsibilities associated with the role of Quality Assurance Engineer, focusing on complaint investigations.KEY RESPONSIBILITIES:This role is primarily responsible for the thorough investigation, assessment, and resolution of all Quality Engineering complaint issues by utilizing various quality...
-
Quality Assurance Specialist II
1 week ago
Round Lake, Illinois, United States Experis Full timePosition Overview:Our client, a leader in the Medical Device sector, is in search of a Quality Assurance Specialist to enhance their operational team. This role is crucial within the Medical Device division, ensuring compliance and quality standards are met effectively. The ideal candidate will possess 1-3 years of relevant experience in the medical device...
-
Quality Assurance Specialist
12 hours ago
Round Lake, Illinois, United States Rose International Full timeJob SummaryRose International is seeking a highly skilled Quality Lab Associate to join our team. As a Quality Lab Associate, you will be responsible for performing biological, chemical, and physical analyses on pharmaceutical products throughout the manufacturing process, ensuring compliance with regulatory standards.Key ResponsibilitiesConduct Critical...
-
Quality Assurance Specialist
15 hours ago
Round Lake, Illinois, United States Takeda Pharmaceutical Full timeAbout the Role:The primary responsibility of this position is to ensure the quality of materials and documentation in the manufacturing process. This involves working on materials release and approval of completed documentation for batch folders following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). The successful candidate will...
-
USA - Quality Assurance Specialist II
2 weeks ago
Round Lake, Illinois, United States Mindlance Full timePosition Overview:This document outlines the employment qualifications and responsibilities for the role of Quality Assurance Engineer focused on Complaint Investigations.Key Responsibilities:This role is primarily accountable for the investigation, assessment, and resolution of all Quality Engineering complaint analysis tasks utilizing various quality...
-
Quality Assurance Specialist
16 hours ago
Round Lake, Illinois, United States Takeda Pharmaceutical Full timeAbout the Role:The primary responsibility of this position is to ensure the quality and compliance of our manufacturing processes. As a Quality Assurance Specialist, you will be accountable for overseeing the release and approval of completed documentation for batch folders, following Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)...
-
Pharmaceutical Stability Analyst
2 weeks ago
Round Lake, Illinois, United States Integrated Resources, Inc ( IRI ) Full timePosition Title: Quality Control Analytical ChemistCompany: Integrated Resources, Inc (IRI)Department: Pharmaceuticals R&D/Stability LabRole Overview:The Quality Control Analytical Chemist is tasked with conducting analytical evaluations, validation, and/or transfer of testing methodologies that support pharmaceutical parenteral products. The primary focus...
-
Laboratory Quality Assurance Associate
2 weeks ago
Round Lake, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 10-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for a total of 40 hours)Role Summary:The Quality Lab Associate I position involves performing biological, chemical, and physical evaluations of...
-
Laboratory Quality Assurance Associate
2 weeks ago
Round Lake, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition Title: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 10-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for the 40 hours)Role Summary:The Quality Lab Associate I role involves conducting biological, chemical, and physical evaluations of...
-
Laboratory Quality Assurance Associate
2 weeks ago
Round Lake, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 ten-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for the 40 hours)Role Summary:The Quality Lab Associate I position involves conducting comprehensive biological, chemical, and physical evaluations...
-
Laboratory Quality Assurance Associate
2 weeks ago
Round Lake, Illinois, United States DivIHN Integration Inc Full timeJob OverviewPosition: Quality Lab Associate ILocation: Round Lake, ILDuration: 6 MonthsShift: Weekend + 2 additional nightsHours: 4 10-hour shifts (Friday through Sunday 10 pm to 8:30 am and two nights of choice for a total of 40 hours)Role Summary:The role involves conducting biological, chemical, and physical evaluations of pharmaceutical products...
-
Quality Systems Change Coordinator
2 weeks ago
Round Lake Beach, Illinois, United States BioSpace, Inc. Full timePosition Overview As a pivotal member of our team at BioSpace, Inc., the Quality Systems Change Coordinator will take on the essential role of managing and overseeing Quality Systems Change Control processes. This position requires a deep understanding of change management and documentation practices, ensuring that all changes are meticulously documented and...