3RD SHIFT CHEMIST

QA Chemist Raw Materials
POSITION SUMMARY: QA Raw Material Chemist will perform testing for quality of raw materials, following all standard operating procedures. Will work with Near-IR instrumentation to increase the efficiency of the raw material identification process. Will work with vendors and manufacturers of raw materials to perform troubleshooting and test methods development. Will occasionally be required to perform sampling of raw materials. Prioritize daily sample testing and perform a variety of laboratory tests on raw materials, in-process and finished batches. Aid in training new Associates.

Essential Functions

• Perform laboratory analysis on incoming raw materials, in-process samples, and finished products per established procedures, including wet chemistry, GC & HPLC
• Performs tests accurately as required for each sample, using designated methods and materials
• Interprets test results, records results and determines if the chemical status of the raw material is within specifications
• Maintain company standards of sanitation and safety
• Sample raw materials per approved procedures
• Coordinate information flow within the laboratory and to internal customers
• Access, input, and retrieve information from the computer systems
• Disposition of raw materials, process samples and finished products for use or sale
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy
• Demonstrate a complete understanding of company and industry safe procedures for processing, analyzing, and storage of hazardous, flammable and raw materials in accordance with local, state, and federal guidelines
• Record deviations in performance not anticipated or indicated in test procedures
• Learn and follow manufacturing processes and work flows, retain program and documentation
• Work with minimal supervision, re-prioritizing work schedules quickly
• Proficient in performing routine GC and HPLC analysis including integration and result calculations
• Become familiar and assist with Method Development Protocols and conduct requisite testing
• Familiar and assist with IQ/OQ/PQ and instrument validation/calibration tasks
• Become familiar and assist with Method Transfer protocols and requisite testing
• Become familiar and assist with SOP creation, review and revision activities
• Ensure Stability protocols and testing processes are adhered too
• Understand and complete supplies/services ordering
• Knowledge of lab instrument maintenance and troubleshooting
• Ability to perform any routine task in the laboratory in an efficient manner
• Provide timely, accurate information to production personnel
• Attend meetings as required
• Complete required training
• Other duties as assigned

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.
Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.
Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.
Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

POSITION QUALIFICATION REQUIREMENTS:

Knowledge: Requires BS/BA degree in Chemistry or related science and thorough understanding of FDA regulations. Education may be offset by progressively responsible experience. Also requires thorough working knowledge of laboratory and/or test procedures. Ability to use laboratory equipment in a safe, efficient manner.

Experience: Bachelor of Science in Chemistry is required; 1 to 2 years’ experience in a laboratory is preferred. Employee must be able to demonstrate the basic fundamentals of Chemistry and a basic understanding of the Quality lab function. Requires a minimum of 5 years Vi-Jon specific QC experience when degree requirement is not met.

Machines, Tools, Equipment and Work Aids: Computer & related programs, laboratory glassware, sampling equipment, chemical reagents, pH meter, viscometer, balance, TOC, Densitometer, HPLC, GC, FT-IR, Federal Register, and standard office equipment.

License(s)/Certification(s) required: None identified

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QC Chemist
POSITION SUMMARY: Prioritize daily sample testing and perform a variety of laboratory tests on raw materials, in-process and finished batches. Review compounding and laboratory records for accuracy and completeness. Investigate customer complaints, OOS/OOT results and implement any corrective action as determined by QC supervision. Aid in training new Associates.

Essential Functions

• Behavior: Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts
• Attendance/Punctuality: Presence at work on time when scheduled is a mandatory function
• * Safety*: Compliance with all company safety rules, procedures, and guidelines is mandatory
• Perform laboratory analysis on incoming raw materials, in-process samples, and finished products per established procedures, including wet chemistry, GC & HPLC
• Prepare samples for chromatographic analysis, prepare standard and reagent solutions
• Maintain company standards of sanitation and safety
• Sample raw materials per approved procedures
• Coordinate information flow within the laboratory and to internal customers
• Access, input, and retrieve information from the QC computer systems
• Disposition of raw materials, process samples and finished products for use or sale
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy
• Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous, flammable and raw materials in accordance with local, state, and federal guidelines
• Record deviations in performance not anticipated or indicated in test procedures
• Learn and follow QC and manufacturing processes and work flows, QC retain program and documentation procedures
• Work with minimal supervision, re-prioritizing work schedules quickly
• Proficient in performing routine GC and HPLC analysis including integration and result calculations
• Knowledgeable of OOS/OOT and Customer complaint investigations
• Become familiar and assist with Method Development Protocols and conduct requisite testing
• Become familiar and assist with IQ/OQ/PQ and instrument validation/calibration tasks
• Become familiar and assist with Method Transfer protocols and requisite testing
• Participate in Annual/New Supplier Validations protocol, sample transfer and testing process
• Become familiar and assist with SOP creation, review and revision activities
• Ensure Stability protocols and testing processes are adhered too
• Understand and complete supplies/services ordering
• Perform contract manufacturing protocols and work flows
• Knowledge of lab instrument maintenance and troubleshooting
• Ability to perform any routine task in the laboratory in an efficient manner
• Provide timely, accurate information to production personnel
• Attend meetings as required
• Complete required training
• Other duties as assigned

Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.
Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.
Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.
Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

POSITION QUALIFICATION REQUIREMENTS:

Knowledge: Requires BS/BA degree in Chemistry or related science and thorough understanding of FDA regulations. Education may be offset by progressively responsible experience. Also requires thorough working knowledge of laboratory and/or test procedures. Ability to use laboratory equipment in a safe, efficient manner.
Experience: Requires 1-2 years of progressive Quality Control experience, with proficiency in a laboratory environment. Demonstrated interpersonal skills are vital. Must be able to work well independently and make quick decisions under pressure. Requires a minimum of 5 years ViJon specific QC experience when degree requirement is not met.
Machines, Tools, Equipment and Work Aids: Computer & related programs, laboratory glassware, sampling equipment, chemical reagents, pH meter, viscometer, balance, TOC, Densitometer, HPLC, GC, FT-IR, Federal Register, and standard office equipment.
License(s)/Certification(s) Required: None identified
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Specialist Quality Assurance
Summary:
Processing all Standard Operating Procedures for the MO site. This includes keeping the intranet site updated, and maintaining a SOP training database. Compiling and processing the Annual Product Reviews for drug products and required cosmetics. Maintaining and trending quality data for executive reporting, internal and external failure analysis.

Essential Duties and Responsibilities:

• Ensuring all SOPs are processed in a manner to ensure compliance to the GMPs. This includes maintaining change control records for SOPs, issuing out required review records, acquiring QA approval along with applicable department approval before making a SOP active on the intranet.
• Maintaining a SOP training and GMP training database for this site. Monitor and report to supervisors on outstanding training. Conduct training as needed.
• Maintaining the Annual Product Review data for the site. This includes compiling data from QC, PD, batch records, etc. The annual reviews are for all drug products and cosmetic products for some key customers, including Canada GVP.
• Coordinate investigation and resolution on all customer complaints assigned to MO operations. This includes timely reporting of any adverse events or high concerns to management.
• Assist with Quality Metrics reporting and Master Data as backup.
• Assists QA Director and VP of Quality with special projects.

Supervisory Responsibilities:

Education Requirements:
A Bachelor’s degree in a related filed is preferred.

Experience Requirements:

• Proficient in Microsoft Office products including a minimum of 2 years computer software experience in a work environment
• QA, QC or working in a GMP environment is preferred.

Competencies:

Certificates, Licenses, Registrations:
N/A

Travel:
N/A

Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

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Specialist Quality Microbiologist
Summary:
Prioritize daily sample testing and perform a variety of microbiological tests on raw materials and finished batches. Identifies, isolates and studies micro-organisms, bacteria and their byproducts. Investigate OOS/OOT results and implement any corrective action as determined by QC Management. Aid in training new Associates.

Essential Duties and Responsibilities:

• Perform and document testing in accordance with cGMP. Testing includes, but is not limited to, finished product analysis and preparatory testing of newly developed products, raw material analysis, and organism identification.
• Maintains inventory levels of reagents, media and stock cultures.
• Troubleshooting, maintenance and calibration of laboratory equipment are expected.
• Organize workload of laboratory and provide management with feedback of overall laboratory performance.
• Work on special projects as assigned or requested.
• Modify SOPs as necessary and ensure that procedures are in place for all tasks within the laboratory.
• Perform general housekeeping duties.
• Coordinate information flow within the laboratory and to internal customers.
• Access, input, and retrieve information from the QC computer systems.
• Disposition of raw materials, process samples and finished products for use or sale.
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy.
• Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous and/or flammable products and raw materials in accordance with local, state, and federal guidelines.
• Document deviations in performance not anticipated or indicated in test procedures.
• Be or become thoroughly familiar with QC and manufacturing process and work flow, QC retain program and documentation procedures.
• Work with minimal supervision, re-prioritizing work schedules quickly.
• Be proficient in performing traditional plating techniques and routine Celsis analysis.
• Become familiar and assist with OOS/OOT and Customer complaint investigations.
• Become familiar and assist with Method Development Protocols and conduct requisite testing.
• Become familiar and assist with SOP creation, review and revision activities.
• Become familiar and assist with supplies/services ordering process.
• Become familiar and assist with instrument maintenance and troubleshooting.
• Must be able to perform any routine task in the laboratory in an efficient manner.
• Participate in meetings as required.
• Complete training assignments as required.
• All other duties as assigned.

Supervisory Responsibilities:
N/A

Education Requirements:
Bachelor of Science degree in biology with emphasis in microbiology.

Experience Requirements:
1-2 years in a microbiology lab. Aseptic techniques, gram staining, membrane filtration, operation of the autoclave, preferred knowledge of Biology, ADI or other rapid method ID systems, serial dilutions, standard plate counts and work safely with potentially pathogenic microorganisms.

Competencies:

• Thorough knowledge of bacterial colony morphology, diagnostic media and rapid methods of organism identification, pathogenic effects of microorganisms, potential environmental contamination factors.
• Has a thorough knowledge of laboratory operations and is highly capable of utilizing scientific judgment to assess problems.
• Has an extensive knowledge of GMPs and USP regulations in reference to microbial testing.

Certificates, Licenses, Registrations:
N/A

Travel:
N/A

Work Environment:
Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb. Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.

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JOB TITLE: Specialist Quality
DEPARTMENT: Quality Assurance
FLSA: Exempt, Salaried
JOB REQUIREMENTS

EDUCATION: Minimum of Associates Degree orcollege level course work which includes: 1 year of general chemistry, Basic English (English/Composition 101, etc…). Technical Writing course work preferred. Some computer course work preferred. Previous experience can be substituted for education.

EXPERIENCE: A minimum of 5 years of experience in a regulated industry is required. A background in chemistry preferred. Personal computer proficiency required.

SPECIAL KNOWLEDGE: Must have working knowledge of computer usage including Microsoft Word, Microsoft Excel, Microsoft Access and SAP, and other word processing, database, or spreadsheet programs

TECHNICAL SKILLS: Works well with computers (ability to create spreadsheets, databases, etc…), Technical writing skills. Ability to analyze data & track trends. Ability to analyze problems utilizing basic quality tools (pareto charts, root cause analysis, gap analysis, etc…)

NON TECHNICAL SKILLS: Requires excellent writing and organizational skills.

PHYSICAL REQUIREMENTS: CRITICAL TO JOB: Standing and walking – 30% of time on job; sitting – 70% of time on job; climbing stairs and ladders, repeated motion of hands (typing) – 30% of time on job; communicate (talking and listening) – 75% of time on job; identifying colors – 20% of time on job, ability to see. HELPFUL TO THE JOB, NOT CRITICAL: Ability to bend, stoop, and kneel and the ability to visually track moving objects.

ESSENTIAL JOB FUNCTIONS

• Answer Technical specification requests, questionnaires and forms. Review QA Master Data and provide weekly report. All other projects as directed such as CARB. Write and complete response for UL or BV unacceptable reports quality related issues within 10 business days or within allotted timeframe. Enter into SAP Z9 complaint reporting for tracking purposes.

• Update customer specifications through web portals as requested by sales.

• Coordinates the retrieval of quality information (surveys, etc…) for the customer. Communicates and coordinates changes requested by customer (component changes or special instructions).

• Support and conduct Target Inspection process at Distribution Center (DC).

• Maintain retain room and documentation archive at DC. Review records or inspect retains on request to support investigations.

• Projects for QA Director as assigned

Location: 8515 Page Avenue, St. Louis, MO 63114

Job Type: Full-time