Quality Excellence Associate Chemist Jobs

Pay range $40-$55K - salary consummate with experience

This is a full-time position Monday - Friday with hours 8 AM to 5 PM and subject to change

Qualified applicants will have at least a BS degree in Chemistry or Biochemistry and at least one year in Quality Control

Company will not pay for relocation

1) Upon approval of production blends, process receipt of batch ticket in ERP System as directed.

2) Assist in maintenance of Corrective Preventative Action Reports. Provide timely resolution to CPAR events.

Practical computer skills including email, MS Office Suite, Google Suite and database management.

Communicates with Operations and Management teams regarding routine matters in person, via phone and electronically.

$28-32 /hr starting rate (based on experience)

Understands and is accountable for full compliance with safety and other EOHS requirements.

Performs or assists vendors in the installation and qualification phases of laboratory instruments.

Other job duties and projects as assigned.

Demonstrated excellent verbal and written communication, interpersonal, and relationship management skills.

Demonstrate a working knowledge and experience with standard analytical instrumentation and methods.

Typically at least 3 years of industry related experience in analytical science as applied to manufacturing.

Experience in using analytical techniques to prepare solutions.

More than three years of experience in industrial biotechnology manufacturing.

Experience in leadership roles, for example a) technical training of personnel, b) developing SOP's, and c) professional mentoring of junior staff.

Reviews and revises testing and equipment procedures as needed. Performs equipment and procedure qualifications periodically.

Employ sound technical writing skills involving deviation reports, laboratory investigation reports, etc.

Perform or assist with other Quality Unit assigned activities related to MURR facility responsibilities associated with FDA, NRC, and DOT regulations.

Able to independently perform testing on multiple radiopharmaceutical batches manufactured on a weekly basis.

Assists peers with method development and validation activities.

Contribute to the proper maintenance and organization of the laboratory, laboratory equipment, supplies, records, and samples.

Assists users of analytical data (Management, technicians, and production) with the interpretation of the analytical results.

An understanding and experience in a variety of analytical techniques.

Strong troubleshooting experience of analytical instruments.

Takes leadership role in the assurance of safe laboratory operations and maintain quality of data generated.

Resolves quality issues including instrument reliability, accuracy, precision, turnaround time, capability, and value.

Works with the Analytical/PT group to develop new or improved analytical methods or new methodologies.

Experience with electronic laboratory management systems (E.g., LIMS, LES, ELN)

Strong self-management and organizational skills.

Bachelor (4-year college) degree in Chemistry, Biology or Microbiology and Relevant experience in a chemistry lab.

Experience with Empower3 and TrackWise.

Experience with change control, analytical and deviation investigations, including root cause analysis and CAPA.

Laboratory experience with HPLC and CE instruments.

2 or more years of quality or laboratory experience

Knowledge in chemistry, math, and general science

Experience in safe handling of chemicals

Strong oral and written communication skills

4 or more years of quality or laboratory experience

Perform laboratory operations, evaluate products, and provide technical support

Computer Skills with working knowledge of MS Office Suite (Outlook, Word, and Excel).

Participate in continuous improvement activities looking to pursue laboratory best practice and offer appropriate feedback when non-value added activities are observed.

Excellent written and verbal communication and interpersonal skills.

Expiry Date: 12 June 2023

Conduct testing of in-process materials, finished product, and stability samples in support of production at the ASPEX client Manufacturing site.

Maintain QC Analytical Laboratory in compliance with regulatory standards and site procedures.

Install columns requiring fine motor skills (about 16 adjustments per hour)

1+ year of laboratory experience

Knowledge of Gas and liquid chromatography.

Basic knowledge of statistics and statistical variations.

Perform advanced gas chromatography and/or liquid chromatography operations according to documented methods to evaluate stock and/or custom chromatography products.

Select and prepare appropriate standards and solutions as required for product evaluation.

Experience in facilitation, negotiation, and influencing skills. Ability to drive change.

Drive Quality Operations Strategy ensuring strategic initiatives are structured and managed to assure acceptable delivery.

15+ years’ experience in GMP pharmaceutical, biologics and/or medical device manufacturing; 5+ years of progressive people leading experience required

Lean Six Sigma Black Belt certification is required

Ability to manage multiple projects and work with cross-functional teams.

Excellent communication, organizational, computer, and interpersonal skills.

Minimum 4-6 years’ experience, including graduate or postgraduate research and/or industry experience.

Experience with dispersions, coatings, and/or interface science

Strong analytical skills as applied towards solving complex physical science challenges.

Excellent written and verbal communication skills, team player and ability to effectively communicate research plans, proposals, and results.

Extensive experience with nanomaterials, composites, and materials processing

Experience with a variety of analytical methods like DLS, TGA, DSC, Rheometry, etc.

Support the design, qualification, and commissioning of facilities and equipment in relation to parenteral radiopharmaceutical drug product manufacturing.

Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

BS/BA degree in chemistry, chemical engineering, or a related discipline. Experience with radiopharmaceuticals and/or use of radioactive materials is preferred.

Strong quantitative reasoning skills and a background in mathematics.

2 years of relevant industry experience in parenteral drug product manufacturing, and/or process support/development.

Experience working in a pharmaceutical GMP manufacturing environment is preferred.

Lead Engagement Reviews: Own assignment of LER and management of end-to-end process (including Reviewer check-ins)

Accountable for building, organizing, and driving the O/OP knowledgebase of risks and associated mitigation strategies by market offering/solution

Continually build FOCUS knowledgebase to include promoting offering/solution guidance/questions for consideration in the risk consultations

Experience Requirements: Minimum 10+ years

Strong executive presence; Ability to manage and interact with senior leaders

Education: BBA/BA/BS in related field, Masters' Degree is desirable

Basic laboratory skills including mathematical skills for analytical calculations as defined per procedures including basic rounding and significant figure.

Must be able to perform gowning requirements.

Perform routine chemical raw material testing through final analyses. Testing is process driven involving SOP, JIB, CQP and Spec procedure/guidance

Interpret and analyze results. If any results are out of limit/specifications, initiate and complete an investigation.

Participate in continuous improvement activities, problem solving events, and cross-functional teams requiring independent judgment and decision making for solutions.

Assure compliance of manufacturing and quality control operations per all required procedures, standards and regulations.

Reviews and revises testing and equipment procedures as needed. Performs equipment and procedure qualifications periodically.

Employ sound technical writing skills involving deviation reports, laboratory investigation reports, etc.

Perform or assist with other Quality Unit assigned activities related to MURR facility responsibilities associated with FDA, NRC, and DOT regulations.

Able to independently perform testing on multiple radiopharmaceutical batches manufactured on a weekly basis.

Assists peers with method development and validation activities.

Contribute to the proper maintenance and organization of the laboratory, laboratory equipment, supplies, records, and samples.

Reserve your spot by clicking “Apply on Company Site” and follow the steps outlined.

Our employer partners are equal opportunity employers.

Pay: $61,940.00 - $128,160.00 per year

Assists manager(s) in corrective and preventive action requests for the laboratory

Perform other duties and responsibilities as assigned.

5+ years of experience in a regulated commercial lab environment (Required)

1+ year of protocol and report writing experience (Required)

Advanced knowledge of routine & non-routine testing methods OR Bachelor Degree in Chemistry and similar disciplines (Required)

7+ years of oil, gas and chemical industry experience in a laboratory (Preferred)

Computer skills including email, spread sheet, presentation and data base management.

Understands and is accountable for full compliance with safety and other EOHS requirements.

Performs or assists vendor in the installation and qualification phases of laboratory instruments.

Other job duties and projects as assigned.

5 or more years of experience in an analytical laboratory.

Good technical, communications, and interpersonal skills.

Employ sound technical writing skills involving non- critical deviation reports, planned deviation reports, laboratory investigation reports, etc.

Perform or assist with other Quality Unit assigned activities related to MURR facility responsibilities associated with FDA, NRC, and DOT regulations.

Perform testing on multiple radiopharmaceutical lots manufactured on a weekly basis

Contribute to the proper maintenance of the laboratory, laboratory equipment, supplies, records, and samples.

Maintain Quality System documents and records

Detail oriented individual committed to high quality work and documentation

Prior experience with instrumentation (e.g. FTIR, viscosity, pH, TOC, etc.) is required.

Strong organizational skills and extremely detail oriented.

Excellent written and verbal communication skills.

Report any deviations from procedures and normal practices to manager. Investigate Out of Specification (OOS) deviations.

Attend any recommended training requested by the manager.

Perform other duties as requested by the Quality Supervisor and/or Quality Manager.