Qc Analytical Lab Ops Specialist I 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.

Complies with and supports continuous improvement of the ISO 17025 accredited laboratory Quality Management System.

Performs labeling and logging of samples using the Laboratory Information Management System (LIMS).

Processes, organizes and summarizes data and computerized results of analysis through the Laboratory Information Management System (LIMS)

If necessary provide remedial training or continuing education to improve skills.

Experience with ISO 17025, GMP, GLP, or similar certification process

PRIOR CANNABIS LAB TESTING EXPERIENCE IS REQUIRED ***

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.

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;

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.

Acknowledge and process all quality documentation regarding production

Associates Degree, technical trade school or minimum 4 years industry technical experience

Chemical solvent testing experience preferred

Strong Customer Service Skills with the ability to follow up and follow through

Flexibility with scheduling and adapt to business requirements & needs

Follow and engage in the safety initiatives/programs & protocol at the site.

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. .

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.

This is a rotating shift position. Salary is based on qualifications and experience.

Knowledge of Analytical Chemistry preferred.

Perform Quality Control tests on finished products according to established procedures.

Review all analysis results with supervisor, and grade all finished lots when testing is complete.

Enter all data into the laboratory database system.

Retain all finished samples and keep the retain sample room well organized and clean.

Follow process guidelines and expedite quality concerns to management

Experience with food safety (e.g., AIB certification, operations prerequisite programs, UP lights, etc.)

Experience with audit compliance (e.g., monitoring, documentation, variance explanation, etc.)

Experience with product changeovers (e.g., CIP, flavor changes, sanitizing, setting formulas, etc.)

Experience operating testing instruments (e.g., Carbo Qc, HPLC, Densitometers, Water Testing, etc.)

Experience following standards of operations (SOPs) (e.g., following procedures, etc.)

Demonstrate prototypical leadership skills, planning, and organizational capabilities

Experience with peptides and oligonucleotides

Documented experience working in cGMP environment

Lead product attribute criticality assessments from candidate nomination through IND, and ultimately commercial registration.

Oversee laboratory investigations and the review of investigation reports

Collaborate with CMOs and other external partners and assess opportunities stateside and in Europe & Asia

Perform sample management, laboratory testing, analysis and utilize standard procedures.

Experience and skill in following directions and instructions

Experience and skill in general laboratory practices and maintaining an organized workspace

General knowledge of scientific equipment and capabilities in laboratories is useful

Strong interpersonal, verbal, and written communication skills

Ensure sample analyses are done per standard operating procedures and done in a timely manner

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

Iii. Minimum Education, Experience, Skills

Responsible for generating management review metrics and KPIs.

Provides mentoring and Conducts Performance Management of direct reports.

Performs managerial duties, as assigned, in support of QC operations such as resource management, routine data and investigation review.

Must possess skills and knowledge of implementing and managing a compliant stability program.

Manage the Biochemistry Group operations in support of production by ensuring the timely execution of QC testing.

Skills and knowledge in immunological and ligand-based test methods such as ELISA, Western Blot and SDS-PAGE testing is also desirable.

Experience in executing phase appropriate method qualifications and validations.

Excellent written and verbal communication skills including ability to write reports for method verification/qualification/validation.

Provides technical expertise for method development, optimization, verification, qualification and validation.

Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned.

Advanced knowledge of cGMPs, safety and data integrity as relevant to a QC laboratory.

Work under the supervision of the Quality Control Department Manager, with guidance from the Conversion Department Supervisor and Leads.

Minimum age requirement of 18.

Ensure that all produced goods meet quality specifications and adhere to GMP (Good Manufacturing Practices) and SOP's (Standard Operating Procedures).

High school diploma or GED equivalent.

Accurate reading of a tape measure.

Self-directed and able to multitask.

Managing project teams specifically assigned responsibilities related to sampling, environmental chemistry, laboratory analysis, data validation, and/or data management.

Serving as prime point of contact with clients, management, and subcontractors.

Familiarity with analytical database management systems such as LIMS, Microsoft Access, SQL, Locus EIM, EQuIS, and GIS desired.

Working collaboratively with HGL's Chemistry manager for ensuring resources for chemistry technical operations.

Excellent verbal and written communication skills

Working knowledge of instrumentation used for environmental analysis (e.g., LC-MS/MS, GC/MS, ICP, GC-ECD, IC, etc.)

Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.

Involve in supply management to ensure there are sufficient reference standard, reagents, supplies prior to your testing.

3 years of hands on experience with HPLC and UV instrumentation and chromatographic software.

Follow current test methods and/or protocols to perform analytical testing.

Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.

May assist with troubleshooting of assay methods and equipment.

Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

Author or revise SOPs, qualification/validation protocols and reports.

AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR

High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience

Deep knowledge of GMP, SOPs and quality control processes.

Deep written and verbal communication skills.