Job Purpose: To contribute to the success of our customers by ensuring first pass quality of Finished Goods or Packaging Materials as assigned.Job Duties and Responsibilities: (Percentages priority and approximate time focus)1.Ensures flawless Lean execution of the Inspection Flow Cell.
· Ensure compliance with all applicable SOPs, Work Instructions, Test Methods, and Standard Work.
· Ensures compliance with good documentation practices (GDP).
· Ensures that non-conformances identified through inspection activities are communicated to the appropriate parties (internal and external).
· Ensures that non-conformances related to vendor provided materials are dispositioned in a timely manner.
· Ensures accurate and timely completion of cell records, including all digital transactions regarding inventory.2.Ensures material inspections (packaging materials and/or finished goods) required by SOP or customer(s) are aligned to customer and regulatory requirements.
· Management of a visual system which ensures inspections are completed in a timely manner which supports the needs of the delivery value stream.
Ensures finished goods and packaging materials are in accordance with customer and regulatory requirements per acceptable quality level (AQL).3.Utilizes data to focus improvement efforts so customer requirements and regulatory regulations are met.
· Accurately records all inspection data and pertinent information in inspection database Ensures inspection cell is appropriately collecting and reporting first time right (FTR) data.
Ensure that any vendor non-conformance event which results in a vendor CAPA is resolved in a timely manner.4.Management Competencies
– Develop and maintain an organization of high performing people who are aligned with the company’s Vision, Purpose and Values by providing leadership and guidance _
– finds and retains the right people in each position and selects the right candidate._
– provides employees the skill and information they need to perform their jobs successfully and follows through to ensure learning._
– coaches employees to succeed and develops them for the future._
– addresses unacceptable performance in a way that causes improvement._
· Performance Evaluation
– objectively values and defines performance against outcomes and standards and supports managers in the Apex assessment process._
· Employee development
– follows a plan to develop performance and prepare people in their career development._
– knows how to document employee performance and construct a case leading to correct termination decisions.5.Ensure [drug] label control and issuance processes are aligned to regulatory requirements and are effective.
Ownership of process which includes the issuance and reconciliation of labels is aligned to support the delivery value stream needs.
Ensure all drug labels are controlled and reconciled according to regulatory requirements.6.Understand and maintain a culture of “lean action” within the department so that we live lean better than any organization.
Implement and maintain standards and processes that eliminate waste throughout the department.
Apply and utilize “lean tools” to permanently implement improvements.Ensure standard work is in place and being used within the affected flow cell.
Institutionalize 5-S in all aspects of the department.
(Sort, Straighten, Shine, Standardize, and Sustain)7.Perform other work as assigned Direction and oversight: None.Qualification and Skill Requirements:Prior Experience:Prefer 1-3 years experience in a manufacturing quality role.
Prior audit experience required.
Knowledge Requirements: Experience normally acquired through a 4-year college degree in Chemistry, Biology or related science discipline and/or equivalent experience is needed.
To be effective, this position requires the ability to multi task, demonstrate a sense of urgency, and the ability to organize.
Licenses and Certifications: None Certifications or required class attendance: NoneWork Requirement:This position may require significant work hours beyond the normal workday based on the demands of the business cycle, customer volume of business, and specific sales efforts underway.
It has a moderate to high demand for tight deadlines.
This position entails work of a cyclical nature.
This position will experience moderate interruption in workflow, starting and stopping for production and customer requirements.
Travel is limited.
Physical Requirements:This position requires:Frequent (4 to 6 hours per day) standing and walking.
Infrequent/Moderate (2 to 4 hours per day) bending, pushing, pulling, climbing stairs, reaching, lifting and grasping.
Infrequent/Moderate (2 to 4 hours per day) repetitive motion, hand/wrist movement.Infrequent/Moderate (2 to 4 hours per day) working at a computer terminal.Sensory requirements: Good eyesight, normal hearing, and fluent in the English language.Working Conditions:Indoors, seasonally cold, hot and humid.Will be exposed to various fragrances which at times may be at elevated levels.Moving and lifting objects, sometimes 50 lbs.
frequently.Work Schedule:This position usually works for 8 hours during a shift.
However, hours of work are flexible and will fluctuate based on the needs of the business and the customers.
The job may require a maximum of 5 hours of work beyond the normal 40 work-week schedule depending on work demands.
The work hours can vary depending on customer requirements and staffing.Technical Competencies:Must demonstrate excellent verbal and written communication skills.
Is accurate, precise and pays attention to detail.
Is well organized and thorough in work habits.Familiar with the utilization of a PC and e-mail systems.Is proficient at Microsoft Windows XP and Microsoft Office XP or higher.Able to work independently and prioritize tasks.Able to operate measurement devices (calipers, scales, ruler, etc.).Can read and write at a 12th grade level.Can read and follow specifications written in English.Can perform mathematic addition, subtraction, multiplication, and division using all units of measurement.Can compute rate, ratio and percent.