Qc Data Review Specialist Jobs

Self-starter with strong attention to detail, organization, and time management skills.

Two years of relevant industry experience required.

Previous experience in quality assurance or a similar field desired, specifically in processing controlled documents.

Solid knowledge of relevant regulatory standards preferred. ISO 13485, CFR 21 Part 820

Knowledge of Design Control preferred.

Excellent communication skills, both verbal and written.

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Bioassay experience (ELISA, cell-based relative potency assays, PCR, Flow cytometry for method establishment and routine testing) required.

Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

Excellent written and oral communication skills.

Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.

Voluntary benefits including short & long-term disability, life, accident, critical illness insurances

Five years' experience in process optimization, operations, or business management.

Responsible for providing Daily / Weekly updates to On-site Management team regarding all QA/QC issues.

A bachelor's degree in business administration, process management, or operations.

Provide timely and relevant reports and analysis of key trends for managers as required.

Comply with all relevant company safety rules, procedures and guidelines. To be aware of responsibilities under the company safety policy.

Deliver a quality training experience to our employees.

Additional Knowledge, Skills and Abilities may be required for individual positions.

Error-free data entry skills required.

2-7 years: Data Entry Exp.

Performs open-source research to identify addresses to be used by process servers.

Responsible for assisting in all areas of the department with routine daily functions as necessary.

Perform other related duties as assigned.

Experience in file management and maintenance.

Experience in Microsoft Office and Data Entry.

Sorts and reviews quality records for deficiencies returning incomplete records to the team for resolution.

Scans and maintains the quality records and files, ensuring they remain updated and readily accessible.

Enters Material Test Reports data into the database, reviews, and accepts the material for fabrication.

Nucor Towers & Structures Inc

Experience with a LIMS (Laboratory Information Management System) system and Empower.

Strong self-management and organizational skills.

Strong understanding of FDA guidelines, Compendial and cGMP requirements.

Trackwise experience (change controls, Investigations, Activity Planning).

Laboratory experience with HPLC and CE instruments and Testing.

Previous experience testing by compendia methods.

Requires a minimum of 3+ years of related experience.

Experience with the following preferred:

Experience with UV/Vis Spec and Karl Fisher is preferred.

Major duties and responsibilities include:

Bachelor’s degree in medical technology, Chemical, Physical, or Biological Science.

Chemicals, pH meter, and metric balance

Proficiency in LIMS and Quality Management software packages

Knowledge and/or extensive knowledge of GxP regulations

Two-Four (2-4) years’ experience performing data review in a GxP environment

Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable

Issue QC review observations and work closely with the scientific staff to ensure data integrity

Proficiency in LIMS and Quality Management software packages

Knowledge and/or extensive knowledge of GxP regulations

Two-Four (2-4) years’ experience performing data review in a GxP environment

Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR

Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable

Issue QC review observations and work closely with the scientific staff to ensure data integrity

4-6+ years of industry experience or equivalent.

1+ year of experience as a trainer.

2+ years of experience in microbiology testing and environmental monitoring.

Working knowledge of QC laboratory operations.

Advanced technical experience in microbiology techniques such as gram stain, endotoxin, growth promotion and sterility testing.

Experience working in a GMP environment.

Perform in-depth technical data reviews of all analytical and microbiological testing performed on finished products - ensuring compliance with GMPs.

Perform and drive in-depth laboratory investigations to completion. Determine root cause and propose appropriate CAPAs, and support instrument troubleshooting.

Lead the organization from a compliance perspective by participating in and representing the QC laboratories in audits of the facility

INCOG BioPharma Services are looking for a new team member!

Intrigued? Send us your resume at [email protected] or you can find more information on our website.

Knowledge of Quality Management Systems and LIMs systems

Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills

Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills

Data Review of Raw Material, Release and In-Process testing, Stability, Cleaning Verification samples, Microbiological testing, and Analytical test method Qualification/Verification/Transfer/Validation

Strong technical knowledge of various analytical equipment, techniques, and methodology (e.g. liquid chromatography, pH, iCIEF, ELISA, SEC, CE-SDS, TAMC)

Interaction with QC Analysts and Group Leaders as well as managers of other departments as needed

Requires 3-5 years’ experience in Banking Services, branch operations, risk management or related function and two years’ of BSA/AML experience

Bachelor's Degree or equivalent experience

2 years’ experience using Microsoft Office

Good knowledge of Bank Secrecy Act and USA PATRIOT acts

Great communication and writing skills.

To be considered for this position you must meet at least these basic qualifications

Employee Assistance Program – offers benefits to help you manage daily responsibilities

Develop a comprehensive understanding of the commercial and industrial program offerings

Develop advanced technical knowledge in energy efficiency and building science

2 years of relevant experience in energy efficiency, sales, or other relevant area

Strong customer service and client relationship skills, and enthusiasm for energy conservation

Paid vacation, sick, personal and parental leave time