Qc Microbiology Assoc I Jobs in Summit, Ohio

Advanced organizational and time management skills.

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

Advanced knowledge of Quality Systems including SOPs, Change Controls, Deviations, CAPAs, and Risk Management (including Assessments and FMEA).

Advanced knowledge and understanding of industrial/pharmaceutical microbiology, aseptic manufacturing, environmental control, and monitoring, and compendial and rapid microbiology methods.

Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences.

Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making 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.

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.

Strong organization and time management skills.

Minimum of 1 year of people management experience

Communicate with 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.

An equivalent combination of experience/education is acceptable.

Achieve and maintain gown qualification for sterile environments.

Technical skills in microbiology to include, but not limited to aseptic technique, sterile gowning, and pipetting are required.

Excellent computer, documentation, communication, and organizational skills required.

Experience in cGMP environment preferred

Experience with sterility, mycoplasma, environmental monitoring, and water testing preferred.

Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, EU as related to QC activities.

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)

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.

Oversee and participate in critical process monitoring (CPM) and in glove and gown qualification for QC and manufacturing personnel.

Experience working in a regulated (GLP, GMP, CLIA) environment.

Glove and Gown / clean room experience preferred.

This Job Will Have The Following Responsibilities

Serve as the Microbiology expert within Quality Control group; supervise 1 direct report.

Clearly communicate Microbiology objectives and activities to other department leads, including Quality Control, Quality Assurance, Manufacturing, Validation, Facilities, and Supply Chain.

Utilizes personal skills and technical abilities to contribute to team and process performance as measured by team and process metrics.

Verify production lot tickets to customer requirements.

Interpret customer requirements for QC approval.

Earned a HS Diploma with 2-3 years of experience in a manufacturing quality product inspection environment.

Must possess intermediate to advanced computer skills

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

Participate in method qualification/validation activities, as necessary.

Analyze, document, and report experimental data in accordance with Resilience requirements.

4+ years of relevant experience

Basic understanding of cGMP requirements

Demonstrated knowledge / thorough understanding of microbiological methods and relevant regulatory guidelines

Strong planning and organizational skills

Experience managing "state-owned" projects with knowledge of higher education facilities requirements.

Experience with design and construction, including all types of building construction methods.

Demonstrated conflict resolution and negotiation skills.

Working knowledge of construction site safety and VOSHA/OSHA Standards

Working knowledge of site/building design with a basic emphasis on construction processes and inspections.

Working knowledge of most Microsoft computer based programs as well as blue beam and/or a pdf writer.

2-5 or more years of clinical Microbiology laboratory experience within a supervisory / management role

Responsible for the hiring, training and development of laboratory and specimen management staff.

Proficient in laboratory knowledge and how to effectively manage a clinical laboratory

Ensure internal Customer support regarding medical/scientific and lab technical issues is provided.

Organize to prepare, review and/or approves SOPs from the various laboratory departments.

Serve as laboratory departmental liaison during government inspections and/or client audits.

Working knowledge of computer programs, including Microsoft Word and Excel.

Effective verbal and written skills.

Good analytical and problem-solving skills.

Good organizational skills and ability to prioritize work.

Part-time Saturday and Sunday 9:30 AM - 6:00 PM

Associates of Science (AS) in biological or related science; or

• Identify and implement manufacturing procedures intended to optimize existing processes and ensure compliance with regulatory requirements.

• Experience in flow assays a MUST

• Experience in bioassays is a plus

Introductory Experience in the use of scientific laboratory techniques, equipment and materials:

• Excellent documentation and communication skills.

• Consistent, dependable, and accurate in carrying out responsibilities

Education or experience in microbiology, math, and chemistry

Experience with GMP and GLP requirements

Experience testing natural products and ingredients

Experience with environmental and allergen testing

Experience using laboratory equipment and documentation systems

Experience writing reports and communicating results

Read test results and notify Lab Management of results that are out of specification;

Reporting and evaluating results and data entry using Labware (LIMS);

Knowledge of chemistry and analytical chemistry fundamentals as related to quality control;

Strong functional and technical skills, strong analytical instrumentation background in quality control and in a production environment;

Excellent written and oral communication skills;

Good organizational skills and great attention to detail;

Position requires a BS in Chemistry with 5-7+ years’ experience as a QC Manager in a pharmaceutical or Biotechnology organization.

Experience leading teams of QC professionals is required.

The position requires experience working in a cGMP environment and experience with documentation and implementation of quality systems.

Provides leadership and communication on all quality control matters with both internal and external groups and customers.

Assures the utilization of appropriate industry/regulatory standards and analytical tools to investigate any questionable results and develops/implements appropriate CAPA.

Develops and implements actions aimed at continuous improvement for the laboratory environment.

Responsible for understanding and implementing the Food Safety and Quality Management System and related activities, including SQF standards:

Meet Skill Level Requirements as determined by Quality Leadership.

Off-site Co-Manufacturer and Supplier auditing skills.

Preferred education: Bachelor’s Degree in Food Science or science related college level courses.

Expected experience: 2+ years in a manufacturing environment, including employee training.

Excellent analytical skills with attention to detail and ability to demonstrate critical thinking.

o Assist with inventory management:

o Maintain all qualification and validation requirements for entering ISO classified area.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

o Technical experience with computer-controlled automation preferred.

o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

Perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles

Experience in a molecular biology laboratory preferred.

Experience with Sanger sequencing and/or Next Generation sequencing preferred

The essential requirements of the job include:

Act as primary analyst for routine and non-routine sequencing projects, including reaction preparation, analysis, and reporting

Support readiness of the sequencing lab through equipment maintenance, buffer preparation, materials planning and requests

Strong oral and written communication skills

In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology

Previous experience in aseptic manufacturing highly preferred

Positive attitude and strong interpersonal skills

Must be able to work at all NH PCI sites inclusive of remote locations

Strong oral and written communication skills

In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Minimum of 1-3 years demonstrated leadership experience within GMP QC Microbiology

Previous experience in aseptic manufacturing highly preferred

Positive attitude and strong interpersonal skills

Must be able to work at all NH PCI sites inclusive of remote locations

Working knowledge of shop mathematics, and CATIA or blueprint reading and interpretation.

Perform conformity/first article inspections to ensure compliance with FAA approved procedures.

Ensure the proper use and storage of area tools and equipment.

Provide technical support to manufacturing personnel. .

Perform area inspections to ensure compliance with applicable standards and specifications. .

Participate in continuous improvement activities. .

Required Skills, Knowledge, and Abilities

Effective interpersonal skills when working with others.

Ability to follow the specifics of the chart order.

Input data into computer programs.

Ability to operate, perform user maintenance, and troubleshoot high speed scanners.

Ability to pay attention to detail to ensure documents for the correct patient go in the chart.

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

May perform other duties as assigned by QC Micro Management.

Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.

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

Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed.

Strong preference for experience in the following:

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

Utilize a range of electronic systems such as LIMS and document/equipment management software.

Train on and maintain extensive knowledge of current regulatory requirements and relevant internal procedures.

Resolve routine and advanced problems by utilizing appropriate resources. Provide problem solving skills to lead and/or support investigations.

Perform Environmental Monitoring and utilities monitoring.

Perform bioburden, sterility, endotoxin and other routine and more advanced testing.

Perform routine QC testing in accordance with SOPs and cGMP guidelines. Minimal supervision.

Proven history of working in a fast-paced team environment, time management, and meet deadlines.

Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP requirements

Bachelor’s Degree in chemistry, biology, or microbiology with 0-3+ years’ relevant microbiology laboratory experience in Pharmaceutical/Biotech.

Excellent knowledge of Aseptic technique and common microbiological testing

Knowledge of relevant, compliance and guidance documents

Interpersonal skills and ability to contribute to the success of a team