Qc Bioanalytical Analyst Jobs

Complete all needed records in a timely and accurate manner within the service management and documentation systems.

Evaluate documentation of service records against expected standard across a complex product portfolio.

Understand and utilize service workflows and procedures to determine accountable groups and individuals when gaps are found.

Initiate remediation of service records and/or generate customer complaints when gaps are revealed.

Utilize MS Excel analytics to provide service leadership with reporting as well as trending of failures including recommendations for improvement.

Communicate with Customer Technical Specialists, Field Service & Application Engineers to gather more data when needed.

Experience in developing and validating analyses for small molecules, biologics and proteins by LCMS.

Knowledge of basic laboratory safety training is advantageous but not required.

Exceptional oral and written communication skills and ability to network and build consensus within a multi-disciplinary organization.

Drug regulatory experience is desired, particularly regulatory science research.

Developing and validating ligand binding assays for various protein molecules.

Produces reports for reliable, sensitive, and validated methods of analyses (prepares, edit, and designate project reports).

Education and Experience Minimum Requirements

Extensive hands-on experience performing relevant analytical techniques (HPLC, GC, FTIR).

Must have experience with EMPOWER.

Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on continuous improvement.

5-8 years relevant experience in a cGMP pharmaceutical QC environment, or at least 2-5 years with a Master’s degree.

Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications

A clear understanding of the Bank's approach to the management of operational risk, or equivalent experience gained in other organizations.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

Understand the organizational structure, Key management personnel, and primary objectives of the LOBs supported.

Serve as lead resource and Provide guidance to the LOB on risk management issues.

Bachelor's degree in related field or equivalent experience.

3 years of experience, banking experience preferred.

Identify opportunities for improvement and performance trends, and report findings to CMS' servicing management.

Come join our amazing team and work remote from home!

Maintain consistent attendance to ensure fulfillment of essential duties and responsibilities.

High School Diploma or equivalent work experience required.

Two (2) or more years of loan servicing call monitoring, call center or quality assurance experience required.

Working knowledge of loan servicing (customer service, collections, home retention, debt recovery, etc.)

5-7 years of related experience. Lab experience required. Experience in Biologics/chemistry, GMP regulated environment preferred. .

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

What can we offer you?

Primary responsibility for the day-to-day activities in the QC Chemistry laboratory in support of product release testing

Scientific/technical contributor on cross-functional projects related to all QC Chemistry activities and Bioassay development

Interact and coordinate with Manufacturing on a daily basis.

0 yrs experience (we will train you)

2+ yrs of bioassay lab and/or cell culture experience in pharmaceutical or biopharmaceutical industry

Performs broad spectrum of routine tasks in their functional area

Reviews documented information from their functional area, reports abnormalities

Acts as Lead investigator for Level 2 Non-Conformance and OOS and alert investigations. Prepares investigation plan and summary reports.

Prepares documentation for presentation to Regulatory Agencies.

QUALIFICATIONS (Education/Training, Experience and Certifications

Enters results and raw data for tested materials or products in Laboratory Information Management System as needed.

Bachelor’s degree in a science discipline with knowledge and experience in one of the following areas: Chemistry, Biology, or Microbiology.

MAJOR JOB DUTIES AND RESPONSIBILITIES

1-3 years of laboratory experience in related field.

Must have applied working knowledge of various laboratory instrumentation.

Minimum 2 years of relevant work experience

Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Excellent written and verbal communication skills

Experience in a Quality Control setting

Experience within Biopharmaceutical or Pharmaceutical industry

Work experience in Cell and/or Gene Therapy or Biologics

Performs other departmental duties as assigned by management

1+ year(s) experience of lab experience

Physical requirements include stooping, standing, climbing and occasional lifting of up to 50 lbs

Good verbal and written communication skills

We are looking for professionals with these required skills to achieve our goals:

Perform testing following written methodologies and report results which are clear, defensible and right the first time.

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.

Knowledge of basic laboratory skills and proper techniques for routine operation of analytical instruments

To ensure all test methods are in compliance with cGMP and Pharmacopeia requirements

To develop skills in analytical science and keep up to date with latest technologies in analytical science

Knowledge of personal protective equipment & its use (e.g., lab coats, safety glasses & shoes, etc.)

Knowledge of basic chemistry, advanced math including algebra

Experience of ICHQ2 Validation of Analytical Procedures

Recognize and report potential quality problems to management.

Analyze retrieved data and prepare reports for laboratory management.

Flexibility – Various shift options (shift premiums for off-shifts) and remote work policy

Training & Development – In-house leadership development program & support of continuous learning (training, seminars and certifications)

Coordinate contract laboratory testing and review results. Assist in the qualification of contract laboratories.

Some Quality Control or Quality Assurance work experience in an FDA-regulated industry, preferably dietary supplements or pharmaceuticals is preferred.

Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.

Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.

Demonstrated working knowledge related to specific functional activities.

Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.

Must have excellent record keeping, written and verbal skills.

Perform microbiological/ biochemical/ chemical analyses of in-process product, facility and utility testing under cGMP to meet specified timelines.

Participate in assay development and qualification

Knowledge of cancer biology, and immunology and T-cell biology.

> 2 years’ experience in execution of cell-based and /or flow cytometry methods preferred.

Prior experience in CAR-T cell therapy development preferred.

Knowledge of Spectral flow cytometers and hands on human PBMC preparation preferred

Strong critical thinking and problem-solving skills

Proven interpersonal and communication skills.

In this position, the QC Analyst will be responsible for the following duties in the QC Laboratory and Plant.

Ensuring sodium bicarbonate is produced following FDA/GMP, USP and customer guidelines.

Operation of laboratory analytical equipment including ICP, UV/VIS, Particle Size and Wet Chemistry Analysis.

Inspections of manufacturing and packaging raw materials.

Analytical testing of finished product produced at the Green River plant.

Previous experience in production or manufacturing

Experience in business administration may be advantageous

Strong attention to detail, observation, organisational, and leadership skills

Quality Control Analyst Lead - Responsibilities

Quality Control Analyst Lead - Requirements

Assist with the collection and production of samples to evaluate quality

Strong analytical and time/task management skills

Additional skills and experience that will be beneficial:

The successful candidate will possess the experience or develop the skills to:

Strong hands-on experimental skills and attention to detail

Experience with biological sample preparation and peptide analysis using LC and mass spectrometry is highly desirable

Experience on Waters HPLC and Q-TOF instrument is beneficial

Claims processing experience, data entry, call center with escalation experience

Professional degree or equivalent experience

Attention to detail and critical reasoning skills.

Prefer experience with claims review or other analytical experience.

Strong communication skills, both written and verbal

Sharp critical thinking skills with sound judgment