Analyst I Qc Rg Sequencing Jobs

Basic math skills and computer skills, such as data entry, along with a high level of attention to detail

Technical Skills- Knowledge of laboratory equipment, testing and technique

Demonstrate proficiency in computerized systems, such as Laboratory Information Management System

Manage own time, professional development and accountable for own results.

Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.

Ensure all reagents and reference standards are valid and stored according to requirement.

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

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.

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

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

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.

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

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.

Experience with analytical chemistry, instrumental analysis, data compilation and knowledge of cGMP required.

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

Minimum of one year experience in a quality control analytical laboratory required.

Organizational skills, decision-making skills, and communication skills required.

Knowledge of USP and FDA regulations.

All employees are eligible to participate in our company-wide bonus program

Support other groups or as designated by Management team by providing insights and performing investigatory studies

Manage the lifecycle of each procedure by monitoring performance characteristics

Identify new techniques and instrumentation to expand internal capabilities. Prepare justification for new lab equipment.

M.S. in molecular biology, biochemistry, or microbiology or related field is required. Education in computational biology or bioinformatics is preferred.

Perform NGS testing, including library preparation, data analysis, result reporting

Provide training to Analysts for newly developed methods

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

Solid foundation in statistical models (e.g. knowledge of advanced statistical techniques, their relative strengths, and weaknesses) and/or machine learning.

Excellent communication skills in written and verbal form.

Experience designing and implementing complex software systems, or software with low-level components is desirable but not required.

Proven experience in the development of computational methods for use by others.

Proven experience in data-intensive collaborative projects.

PLEASE INCLUDE A COVER LETTER WITH YOUR APPLICATION ***

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

Minimum of 1 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required

Experience in a Quality Control setting is preferred

Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required

Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required

Knowledge of Good Tissue Practices is 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?

Summarize data in support of management review meetings.

Previous experience working in a GMP environment (2-6 years) conducting analytical assays

Previous knowledge of HPLC and ICP-MS instrumentation

Specific duties and responsibilities of the QC Analyst include, but are not limited to:

Ability draft QC method validation protocols and execute the protocols, as necessary.

Conduct analytical assays on final API product and raw materials.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

1 – 3 years experience in medical device, pharmaceuticals, or other regulated product preferred

Working knowledge of standard laboratory practices and safety

Experience working in ISO Class 7 cleanrooms preferred

Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations

Bachelor’s degree in the biological or chemical sciences or equivalent

Collaborate with Regulatory Compliance to ensure qualifications, preventative maintenance, repairs, and cleaning processes are performed on all laboratory equipment.

Assist with the validation and requalification of laboratory equipment.

6 or more years’ experience in Molecular or Microbiology laboratory.

Previous experience managing a large group to include senior individual contributors and supervisors.

Other: Working knowledge of the quality system.

Charles River Labs in Newark, DE is seeking a Sequencing Lab Manager.