Job Description

Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement of opioid and non-opioid products in a range of therapeutic applications. Founded in 1979, the company is headquartered in Delaware and maintains operations around the world.

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

- Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
- High-purity controlled substances from narcotic raw materials
- Formulation-friendly particle size grades and extended technical packages
- Supporting world-class supply security of controlled substances, from schedule I to schedule III

https://www.noramco.com/

GENERAL PURPOSE OF JOB

Provides technical laboratory expertise to lab personnel and sets the testing priorities for an assigned laboratory shift. Must be knowledgeable on all instrumental and wet chemistry methods pertinent to Noramco Quality Control to ensure timely analysis cycle times and complete any instrument or situation troubleshooting. Ensures that the analysts are performing all duties in compliance with company and regulatory standards. Reviews analytical data and releases materials per applicable procedures and specifications. Investigates deviations and non-conformances and recommends appropriate actions to resolve. Acts as a technical resource for daily interactions with QC laboratory personnel. Secondary functions involve supporting lab improvement projects, method validations, stability analysis, and equipment qualifications. Some analytical testing may be performed to assist the shift analysts as needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Reviews analytical data following method procedures and product specifications to release assigned materials for further processing in a complete and accurate manner. Responsible for understanding the instrumental and wet chemistry methodology to thoroughly troubleshoot, perform root cause analysis for lab investigations, prioritize work assignments and assist the analysts with testing as needed. Ensures that lab personnel follow approved standard operating procedures. Conducts weekly shift meetings and escalates issues to supervision Provides technical expertise to internal customers (i.e. cross-functional departments) and other lab personnel. Interacts with internal operations and other technical personnel, as well as contract laboratories as necessary. Perform and document stability pulls as assigned. Assures accurate and timely input of QC data to information systems: e.g.: SAP, Intellitrack, etc. Demonstrates focus and attention to details (i.e. Right First Time) in all aspects of the responsibilities. Conduct thorough lab investigations utilizing root cause analysis followed by written reports for non-conformance events. Coordinates and performs calibration of new laboratory instruments and equipment to ensure reliable, prompt, precise and accurate test data as directed. Troubleshoots and performs minor maintenance/repair of lab instruments. May coordinate and oversee external vendors during the repair of laboratory instruments for minor maintenance as assigned. Responsible for the setup, IQ, OQ and PQ of new instrumentation and equipment in the QC laboratory as assigned. Maintain an adequately supplied, properly cleaned and safe analytical chemistry laboratory to minimize test delays, test errors and mishaps by using good laboratory and housekeeping practices. Review and revise existing SOP's and other lab documents as necessary. When applicable, adapt existing methodologies to support manufacturing and new products Train laboratory personnel as it relates to specific operations and procedures by instruction and demonstration. Maintain regulatory required documentation, which is current, legible, readily understood, complete and accurate to ensure compliance with procedures and specifications. Supports short and long term projects meeting established deadlines. Responsible for leading and sustaining various projects as assigned. Perform other appropriate duties as assigned by the QC Supervisor. Must be willing to work a flexible schedule to support shift operations.

ADDITIONAL POSITION REQUIREMENTS

Complete understanding and working knowledge of all test methods, procedures, instruments and apparatus for the receipt, labeling, sampling, testing, documentation, release and distribution of all chemical substances associated with Noramco, Inc. Complete understanding and working knowledge of computerized data acquisition, analysis and handling techniques to ensure reliable, prompt, precise and accurate test data using established methods and procedures. Successfully completes regulatory and job training requirements. Performs housekeeping 5S audits to assure lab is continuously maintained in a safe and orderly condition. Remains current in profession and industry trends. Makes a positive contribution through demonstration of ability to improve upon current laboratory practices and quality systems and through ability to learn new skills, procedures and processes. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures. Understands and responsibly performs duties with attention to safety, environmental and quality matters. Items include: wearing appropriate personal protective equipment; recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses); properly labeling and storing chemicals; in addition to all other relevant job requirements. Assumes responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise. Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

SUPERVISORY RESPONSIBILITIES

Ensures the productivity of an assigned laboratory shift. May provide feedback in the performance management process.

EDUCATION and/or EXPERIENCE

Minimum requirements include a Bachelor's degree (B.S.) in Chemistry or related area of study. Must have at least 4 years of direct work experience with modern wet chemical, spectroscopic and chromatographic analyses. Must have at least 2 years work experience in the pharmaceutical/chemical industry or other cGMP/cGLP environment. Must have demonstrated knowledge of chemical manufacturing control operations and GMP/GLP regulations. An equivalent combination of education, training and experience may be used to meet the minimum qualifications.

LANGUAGE SKILLS:

Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure documents. Write technical reports, appropriate business correspondence and standard operating procedures.

MATHEMATICAL SKILLS

Work with mathematical concepts such as calculating solution concentrations (e.g. volume %, weight %, normality, and molarity). Apply concepts such as fractions, percentages, ratios and proportions to practical solutions. Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, co-relational techniques, sampling theory, dimensional analysis, linear regression, ANOVA, and factor analysis.

REASONING ABILITY

Define problems, collect data, establish facts, and draw valid conclusions (e.g. root cause analysis). Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

Ability to make independent decisions within general guidelines and to work under minimum supervision. Must have proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment. Working knowledge of analytical instrumentation use and routine preventative maintenance. Ability to trouble-shoot instrumentation malfunctions following ICMS investigation protocols. Proficient with Microsoft Office software programs, including MS Outlook. Ability to accurately enter data into computer using software applications for data entry and word processing. Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production. Ability to perform under stress in cases of emergency, critical or hazardous situations. Ability to work with others in a team environment. Proven ability to prioritize work of self and to ensure deadlines are met. Strong interpersonal and consultative skills.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel; and talk or hear. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and smell. The employee must frequently lift and/or move up to 10 pounds, and may occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
Noramco strives to treata employees fairly without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.

Job Type: Full-time

Pay: $65,000.00 - $72,000.00 per year

Benefits:

401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Tuition reimbursement Vision insurance
Work Location: In person