Specialist Quality 2Nd Shift

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...