Olm Qc Analytical Technician Ii Jobs

Able to clearly communicate problems and observations with management from other departments.

Manages QC analytical testing and personnel.

Manages day to day operations and weekly testing schedule.

Must have experience in writing technical documents and protocols.

5+ years experience in QC analysis in a GMP environment required

Leads the stability testing program and raw material testing program.

Understanding of testing requirements and concepts

2-4 years of work experience using either GC/MS, or GC-MSMS, with Mass Hunter software or equivalent.

Excellent verbal and written communication skills; clear, organized, detail-oriented

Offers and receives useful and constructive feedback

Undertake all necessary training to maintain the knowledge and expertise required to meet the changing demands of the position and business

Prioritize and prepare all customer samples for analytical testing according to Standard Operating Procedures (SOP)

Follows any and all directives of Quality Management

Follows any and all directions of Quality Management

A high degree of written and oral communication skills

Knowledge of all instruments, function and calibration

1 year experience in Plastic Industry with QC of BOPP Plant

Knowledge of all instruments, functions and calibration of equipment

One (1) year previous experience in similar Quality Assurance lab.

Under the direction of the Quality Assurance Supervisor, performs evaluations of ingredients and products in various stages of production.

Obtains samples of ingredients/product at regular intervals.

Evaluates the samples: weight, color, bake, etc.

Routinely makes recommendations for processing.

Originate and maintain accurate records.

Demonstrated knowledge or experience in:

Knowledge or experience in using computer systems and programs for data reporting, analysis and records maintenance.

Strong data analysis, interpretation and critical thinking skills.

Ability to communicate through effective listening, writing and verbal communication skills.

Sample collection and analysis according to precise established operating procedures.

Perform and validate analyses of product, and process stream samples according to operating procedures.

Experience with the operation, deployment, and administration of laboratory information management systems (LIMS).

Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved

Extensive knowledge of GdPs, GMPs and DS / DP multi-compendial assays (USP, EP, JP)

Excellent communication and collaboration skills

Experience with Waters HPLC, UPLC and Beckman PA800 CE systems

Experience with ELISA based impurity or potency methods

Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)

Extensive experience in separations science (e.g., SEC, RP, IEX). Experience in Molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.

Experience of testing strategy for late-stage program in preparation for BLA filing

Excellent written skill for drafting all the GMP related documents.

Ensure communications occur with stakeholders and partners for all the analytical topics

Author analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.

Requires a full functional knowledge of the laboratory equipment and technique. wet chemistry experience is preferred

Manages individual workflow of daily tests and activities to ensure departmental goals are met.

Required to work on tasks of moderate scope where analysis of situations or data requires problem solving skills.

Excellent computer skills, display proficiency in Excel

Upholds departmental standards as required in a GMP environment.

Interacts with cross functional internal customers at all levels of the organization for resolution of issues.

EDUCATION AND EXPERIENCE YOU’LL BRING

an equivalent combination of education and work experience

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Handle discrepant materials per the documented disposition and document activities in the appropriate systems or paperwork.

Performs simple statistical analysis through the collection and input of data into software applications or manual calculations.

High School Diploma, GED or equivalent experience to perform the responsibilities associated with this position

Possess strong mechanical aptitude, knowledge and skills

Two (2) years' experience in quality control in an aggregate or construction environment

Possess effective coordination, interpersonal and communication skills

Able to obtain state certification

Possess basic computer skills & able to learn new software

Essential Job Duties and Responsibilities

Perform accurate and efficient QC data entry.

This is an entry-level position, so no previous experience is required.

Previous in a laboratory or cGMP environment and/or QC experience is strongly preferred.

Effective communication skills, both written and verbal

Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' Quality System.

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):

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.

Experience with Laboratory Information Management System (LIMS)

Basic computer skills (data entry and attention to detail) in Microsoft

Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

Excellent effective written and verbal communication and interpersonal skills

Experience in biotech or pharmaceutical industry

Experience leading continuous improvement projects.

Follow directions of manager as to daily tasks and expectations for each specific duty.

Comprehensive medical, dental and disability benefits programs

Use accepted methods to inspect, sample, and test aggregates, asphalt, or other materials for the purpose of quality control.

Prepare and record accurate information; maintain test results database.

Maintain all laboratory and field testing equipment.

Follow quality control plans and guidelines as assigned.

One (1) year previous experience in similar Quality Assurance lab.

Under the direction of the Quality Assurance Supervisor, performs evaluations of ingredients and products in various stages of production.

Obtains samples of ingredients/product at regular intervals.

Evaluates the samples: weight, color, bake, etc.

Routinely makes recommendations for processing.

Originate and maintain accurate records.

We offer competitive pay and great benefits including:

High school or equivalent and one (1) year production or technical experience required.

Must have basic math and computer skills.

Good written and oral communication skills required.

Educational Assistance/Tuition Reimbursement, up to $3,000 a year

Unfortunately, we will be unable to offer visa sponsorships to candidates.

Additional responsibilities as assigned by Quality management.

Assist with management of retention materials, laboratory equipment maintenance and repair, and other projects as directed.

Knowledge of basic validation, equipment calibration, equipment maintenance and change requirements

Effectively manage multiple responsibilities and complete tasks on schedule

Position requires occasional overtime as designated by Operations/Quality management. Overtime duties may be outside of direct area of responsibility.

Related experience should be in current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), or medical device Quality Assurance role

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.