Chemical Manufacturing Operator

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
The Chemical Manufacturing Operator is responsible for the batch-wise manufacture of active pharmaceutical ingredients in a safe and GMP compliant manner. The Chemical Manufacturing Operator carries out tasks associated with Chemical Manufacturing utilizing batch logs, standard operating procedures, and work instructions under cGMP guidelines. The Chemical Manufacturing Operator adheres to all safety, quality, and compliance regulations, procedures, and guidelines, with special care given to protect the environment in which we operate. Visit us at www.noramco.com

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Complies with company policies and procedures, established safety procedures, and maintains a safe and clean working environment.
• Oversees manufacturing process composed of steps such as set-up, loading, unloading, processing, drying, documentation, and follow-up.
• Accurately completes batch logs and other documentation to produce product efficiently and in compliance with cGMP and standard operating procedures.
• Proper operation of process controls, DCS systems, pneumatic, hydraulic and electrical equipment as detailed in procedures to product materials in a safe and cGMP environment.
• Recognizes and documents “abnormal” operating conditions with proper response including immediate notification of supervision.
• Inspects components and products of the production cycle for compliance with applicable standards.
• Ability to use SAP to electronically document transactions.
• Inspects components of the production cycle for compliance with standards.
• Makes good use of hold periods for subsequent processing steps. Utilizes idle processing time to perform other production related activities (housekeeping, lean initiatives, training, etc.)
• Understand and participate in operator asset care initiatives.
• Other duties as assigned.

ADDITIONAL POSITION REQUIREMENTS

• 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. Recognizes and reports unsafe conditions and procedures to supervisors immediately with relevant documentation.
• Successfully completes regulatory and job training requirements on time.
• Participates on investigative teams and site group initiatives (PHAs, PSSR, etc.).
• Understands and responsibly performs duties with attention to safety, environmental matters, quality, compliance, and controlled substances handling. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills, accidents, near misses, etc.), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.
• Assists in training operators.
• Makes positive contributions demonstrated by:
• Making suggestions for improvement and recommending solutions
• Providing overtime as needed
• Learning new skills and processes

SUPERVISORY RESPONSIBILITIES
None
QUALIFICATIONS, EDUCATION, and/or EXPERIENCE

• High school diploma or general education degree (GED).
• Work experience in a chemical and/or pharmaceutical environment.
• Two to four years related experience and/or training or equivalent combination of education and experience.

LANGUAGE SKILLS

• Read, understand, and interpret documents such as safety procedures, batch logs, operating and maintenance instructions, government regulations and procedure manuals.
• Write routine reports, operating procedures, and correspondence with supervisory assistance if required.

MATHEMATICAL SKILLS

• Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Compute rate, ratio, and percent and be able to create and interpret bar graphs.
• Calculate figures and amounts such as proportions, percentages, area, and volume.

REASONING ABILITY

• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule format.
• Follow work instructions.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

• Mechanical aptitude of production equipment and processes.
• Ability to safely operate a forklift.
• Use computer software applications including Microsoft Office suite.
• Work well with others in a team environment, influencing people in opinions and behaviors consistent with good leadership examples.
• Perform a variety of tasks, changing tasks frequently, staying focused, maintaining attention to detail, with a focus on Safe and Right First Time production.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is regularly required to stand, walk, climb, band, and stoop. The employee uses hands to handle and feel and must reach with hands and arms.
• The employee frequently is required to talk, hear, taste, and smell.
• The employee must occasionally lift and/or move up to 50 pounds.
• The employee is frequently exposed to weather conditions including occasional extreme heat and cold.
• The employee must be able to qualify for and use respiratory protective equipment.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

Noramco provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Type: Full-time

Pay: From $25.00 per hour

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 12 hour shift

Application Question(s):

• Are you willing to undergo a background check, in accordance with local law/regulations?

Work Location: In person