Quality Assurance Specialist

Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement 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
– Formulation-friendly particle size grades and extended technical packages
– Supporting world-class supply security of controlled substances

https://www.noramco.com

GENERAL PURPOSE OF JOB

Conduct and report on inspections and audits of Noramco and/or Purisys via intra- and inter departments, vendors and other contract facilities subject to Noramco approval and inspection. In addition, perform the Quality Assurance review and release of material to external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES

· Reviews completed documentation (batch logs and shipments) for accuracy, completeness and adherence to cGMP’s and releases materials for all shipments.

· Reviews QC data and prepares certificate of analysis for all materials shipped to customer.

· Conducts in-depth cGMP inspections of inter-departmental facilities and systems.

· Conducts cGMP audits of existing/potential analytical laboratories, raw material suppliers, existing/potential vendor facilities and contract manufacturers.

· Reports inspection findings to department and upper management in a timely fashion.

· Assists in conducting and developing site cGMP training.

· Assists in gathering data for GMP and customer audits.

· Reviews and updates, or acts as GMP consultant in the facilitation of, Standard Operating Procedures for Noramco and or Purisys and or Purisys of Delaware.

· Member of specific project team or teams representing the Quality Services Department.

· Occasionally must move (push, pull or turn) 15kg drums to get ready for shipment.

· Performs Site Quality Walkthroughs

ADDITIONAL POSITION REQUIREMENTS

· Inspects final products.

· Utilizes SAP for posting stock, making usage decisions, changing batch status, recording final inspections, and running batch where used reports.

· Trains employees on QA systems and processes as needed.

· 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 where applicable.

· Successfully completes regulatory and job training requirements.

· Understands and performs duties with attention to quality, safety and environmental matters. Items include: wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.

· Makes a positive contribution as demonstrated by:

· Making suggestions for improvement

· Executing continuous improvement projects

· Ability to work independently within areas of expertise

· Learning new skills, procedures and processes.

· Remains current in skills and industry trends.

· Is available to work on evenings/weekends as needed.

SUPERVISORY RESPONSIBILITIES None

EDUCATION and/or EXPERIENCE

Bachelor’s degree and two to four years related experience and/or training OR Associate’s degree and minimum ten years related experience and/or training.

LANGUAGE SKILLS

· Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

· Strong technical writing skills

· Write routine clear and concise reports and correspondence.

· Effective verbal communication skills.

MATHEMATICAL SKILLS

· Add, subtract, multiply, and divide in all units of measure

· Use of significant figures and proper rounding.

· Transfer units from Standard and Metric.

REASONING ABILITY

· Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists in an effective and customer-oriented fashion.

· Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

· Serve as facilitator, or effectively recommend solutions, in situations involving complex or numerous variables.

· Be able to determine “best” solutions in situations where more than one solution may exist.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

· Use word processing and mathematical software applications and customize them to business needs.

· Works with others in a team environment.

· Work in situations where speed and attention to detail are essential, performing a variety of tasks.

PHYSICAL DEMANDS

· While performing the duties of this job, the employee is regularly required to sit.

· Ability to move, push or pull 15kg drums.

· The employee frequently is required to stand; walk; use hands to finger, handle or feel; reach with hands and arms; and talk and hear.

Qualified applicants will be considered 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: $60,000.00 - $75,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Work Location: In person

Salary : $60,000 - $75,000