Qc Microbiology Assoc I Jobs

Demonstrated experience with the qualification/validation, knowledge of regulatory requirements, general knowledge of biopharm manufacturing process, audit experience.

Manages teamwork through good communication skills to administer personnel policies in accordance with site policies and procedures.

Demonstrated experience of leading others and coaching/mentoring skills

Knowledge of good documentation practices, cGMP, and GPS requirements

B.S/B.A. Degree with a minimum of 5 years post-degree laboratory, manufacturing, or quality control/assurance experience

Strong organizational and communication skills and attention to detail

Understanding of scientific principles, ability to communicate with peers and management.

Provide support for qualification and validation activities as appropriate.

3 years of relevant experience (B.S. Degree), 6 years of relevant experience (A.S. degree)

Knowledge of FDA/EMEA regulations and compliance.

Solid working knowledge of operations/quality systems utilized in QC operations/support teams (e.g. strong test method/scientific base).

Perform testing including (but not limited to):

Monitor and trend EM data and update management on environmental trends. Implement corrective action plans when necessary.

Oversee implementation of new programs and qualifications such as Container closure integrity and headspace analyzer testing.

Reports to the next level line manager

Previous superviosory experience in Quality Control preferred.

QC Microbiology experience performing and validating microbial assays and methods in the biotech and/or pharmaceutical industry.

Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance.

Learn new skills and enjoy new experiences in an engaging and safe environment

learn new skills and enjoy new experiences in an engaging and safe environment

Responsible for coverage of all job duties for QC Tech I Chemist.

Experience in a laboratory environment preferred

Knowledge of analytical instrumentation (GC, HPLC preferred)

Effective communication skills (oral, written)

Basic knowledge of LIS or Lab Management Systems.

Hands on clinical lab experience is needed not so much on the research side***

Generate and maintain proper complaint documentation in compliance with FDA (21 CFR) and ISO requirements.

Must have effective communication and customer service skills both written and verbal.

Excellent technical and problem solving skills of varying complexity

Demonstrated effective interpersonal skills, organization/prioritization skills and a passion for providing superior service.

Basic knowledge of LIS or Lab Management Systems.

Generate and maintain proper complaint documentation in compliance with FDA (21 CFR) and ISO requirements.

Must have effective communication and customer service skills both written and verbal.

Excellent technical and problem solving skills of varying complexity

Demonstrated effective interpersonal skills, organization/prioritization skills and a passion for providing superior service.

Experience with medical devices and equipment, experience with BD equipment a plus. Experience on point of care (Veritor) testing preferred.

Solid AP for studio show, solid AD for live game coverage in PCR, PD Room and remote environments.

Operates with mastery in the digital environment, maximizing server capabilities and utilizing q-cut systems.

Thorough knowledge of current television production technologies and applies knowledge to produce compelling content.

Minimum 2 years practical production experience.

Highly strong bilingual Spanish/English speaking/writing skills.

Strong organizational and communication skills.

Solid AP for studio show, solid AD for live game coverage in PCR, PD Room and remote environments.

Operates with mastery in the digital environment, maximizing server capabilities and utilizing q-cut systems.

Thorough knowledge of current television production technologies and applies knowledge to produce compelling content.

Minimum 2 years practical production experience.

Highly strong bilingual Spanish/English speaking/writing skills.

Strong organizational and communication skills.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Prepare and summarize data in a timely manner for review by QC/QA management.

Excellent verbal and written communication skills.

0 to 2 years of QC/QA experience.

Advanced knowledge of MS Excel

0 to 2 years of GMP/GLP experience

Provides technical leadership through effective project management, status tracking, presentations, and communication.

Within team & site management, serves as External Leadership for the project.

Set requirements; deliverables, and measurable goals & targets, mitigation plans, which are aligned to quality directive, regulatory guidance, business imperatives

8+ years of experience from a GMP environment, required

Advanced knowledge in microbiology and/or in EM/UM, and GMP, required

Excellent technical writing, presentation and communication skills.

Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.

Strong organization and time management skills.

Demonstrated resource management and planning skills.

Communicate with the department and cross-functional management.

Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory guidelines/requirements.

Advanced knowledge/experience with MS Word, Outlook, Excel, MS PowerPoint, Visio, LIMS.

Manages the quality control activities of an organization.

Requires breadth of professional field and industry knowledge.

Manages entry to intermediate level employees of a department or a function with 1 or 2 sections.

Ensures budgets, schedules, and performance requirements are met.

Judgement is required in resolving complex problems based on experience.

10-12 years related experience required.

Write and review equipment qualification documentation

Practical experience with various types of laboratory instrumentation

Troubleshooting skills with analytical methodology and instrumentation.

Strong interpersonal skills and ability to work effectively in a team environment.

Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills

Perform testing in accordance with written procedures for raw materials (USP/EP/JP grade)

Knowledge of cGMP and GLP regulations and compendial requirements

Good communication skills both written and verbal

Experience with in testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, Sterility, and Bacteriostatis/Fungistasis testing

Requirements include following gowning procedures, usually lab coats, gloves and sleeves.

Education Assistance Policy - $5,000 per year for all employees

What can we offer you?

Participates in quality management system requirements including following departmental work instructions, creating records, document control, and addressing corrective and preventative actions

Equipment validation, qualification, calibration, and preventative maintenance

Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements

Associate degree and 1-2 years related experience.

OR bachelor's degree and 1-2 years related experience.

Ensure laboratory compliance with applicable regulations.

May perform other duties as assigned by management

Develop, revise and review SOPs, qualification/validation protocols and reports.

Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.

Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.

Strong technical competency and knowledge of Regulatory guidance and regulations (cGMP, USP, EU, JP and the ISO regulation)

Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices

This person is responsible for the aspects of the following programs as directed by management:

Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable)

Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates)

Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests.)

Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host)

Execute routine Microbial Laboratory work.

Participating in the daily activities and work assignments of research staff.

Planning and coordinating complex research experiments following standard operating procedures.

Working with Principal Investigator(s) to coordinate project activities and establish appropriate reporting procedures.

Contributing to scientific analysis and interpretation of projects.

Establishing and maintaining quality control measures for assigned project operations.

Making modifications to research procedures in collaboration with the Principal Investigator(s) and contributing to the writing of SOPs and protocols.

Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment

Demonstrated resource management and planning skills

At least 2 years of leadership/managerial experience (An equivalent combination of education of experience may substitute)

Regular communication to senior levels of management

Experience of new equipment qualification activities: URS, IQ, OQ, PQ, PVs, etc.

Own and manage CAPAs, Change Controls and other quality records utilizing the site QRM system.

Perform any other tasks/duties as assigned by management.

Knowledge and familiarity of equipment including HPLC/GC instrumentation, Atomic Absorption, UV/Vis and FT/IR Spectrophotometers.

Excellent organizational, interpersonal and communication skills (written and oral) required.

Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Responsible for performing routine testing on raw materials and/or finished product pharmaceuticals in compliance with cGMPs.

Execute wet chemical and analytical methods to assess the purity, potency and stability of drug substances and finished products.