ARx Bulk Operator I-1st or 2nd Shift

1st shift, 6am to 2pm (Monday-Friday), 2nd shift 2pm to 10pm (Monday-Friday), 3rd shift , 10pm to 6am (Sunday-Thursday)

Job Summary Performs production operations as directed to support developmental and commercial business needs. Complies with all established regulatory and company guidelines and procedures.

ARx Operator I (G8) Is An Entry Level Position Defined As Having Been In The ARx Operations Department For Less Than 2 Years. An Operator Can Be Promoted To An Operator II When The Following Proficiencies Are Demonstrated

• Adherence to all safety policies and expectations.
• 100% Training compliance.
• Demonstrates Good Documentation Practices (GDP) in all GMP documentation including cleaning records, chronologs and batch records. No deviations due to documentation issues 6 months prior to promotion.
• Understands Data Integrity (DI) principles; no DI violations 6 months prior to promotion.
• Trained/proficient in at least 2 manufacturing areas within the department (for example Pre-Weigh and Mixing).
• Evaluates ways to improve skill set and works to improve department through participation in 6S, efficiency and continuous improvement initiatives.

An Operator I may become respirator qualified and expand upon mixing expertise with the approval of their supervisor. Respirator qualified Operators must demonstrate a safety mind set and adherence to all respirator guidelines.

Essential Functions

• Works safely; efficiently organizes work activities maintaining proper work-flows and ensures availability and use of proper materials and tools. Supports LEAN 6S activities as requested.
• Complies with company policies, good housekeeping, and safety regulations. Maintains a safe and clean work environment; identifies and corrects unsafe practices, conditions, or acts.
• Trains on policies, protocols and procedures as needed to support ability to execute assigned duties.
• Performs a wide variety of production operations such as material handling, weighing, mixing, coating, slitting, packaging, cleaning/sanitization, etc.
• Performs in-process sampling, inspection and testing as directed.
• Executes assigned responsibilities as directed and according to documented procedures (Quality Procedures, Manufacturing Procedures, Batch Records, etc.), protocols, planned deviations, and training lessons. Understands and complies with Pharmaceutical Manufacturing cGMPs consistent with 21-CFR-211 guidelines.
• Accurately and thoroughly fills out process-related paperwork (e.g. batch records) and operational documentation. Must comply to GDP and DI principles.
• Seeks Lead and/or Supervisory assistance for clarification in the event of any uncertainties or unexpected occurrences; demonstrates a right first time (RFT) mindset by seeking guidance from policies or leads prior to deviating.
• Effectively and respectfully interacts and communicates with other operators, associates, and supervisors; relays information to the next shift as applicable; voluntarily assist others where appropriate.
• Responsible for following all applicable waste handling procedures.

Additional Responsibilities

• Performs other duties and responsibilities as assigned.
• Assists in incident documentation and deviation investigations.
• Assists with preventative maintenance tasks as applicable.
• Supports laboratory (Quality, R&D) activities as applicable.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
• Making improvement suggestions; providing feedback on procedures and practices.

Job Specifications

• Requires minimum of a high school education - some college and cGMP, CFR211 compliant manufacturing environment experience preferred.
• Capable of performing duties involving related steps, processes, and methods.
• Ability to comprehend and reliably follow written procedures (batch records, operating procedures, protocols, etc.) and verbal instructions. Attentive to details and capable of error-free procedural implementation.
• Ability to work with numbers consistently and accurately; able to accurately read, perform numerical calculations and document numbers. Ability to calculate and round to required significant figures. Ability to perform basic mathematical functions and apply basic statistical concepts such as mean (average).
• Ability to maintain flexibility in schedule and routine in response to production schedules changes.
• Ability to wear proper PPE for extended periods of time. Minimally safety glasses, sleeve covers, and gloves. At times, uses of additional PPE including masks covering mouth and nose for extended periods of time are required.
• Adheres to gowning policies as described in MSOP-000010.
• Work environment involves moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, and irritant chemicals; will be required to use personal protective equipment such as masks, gowning, hairnets, gloves, safety glasses/goggles, shields, etc.
• Physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching, or similar activities should be expected; recurring lifting of moderately heavy items (objects 50 - 100 pounds); constant manipulation of utensils for weighing of components, requires common physical characteristics and abilities, such as above-average agility and dexterity.
• Primary contacts are with associates within manufacturing, however, some contact can also be expected with individuals or groups from other internal functions.

HOURS PER SHIFT: 8-10 hours average

ARx Production Operator Requirement MATERIAL HANDLING NEVER 0% REP. RARE 1-2 times/day OCCASIONAL 1-33% 1-32 times/day FREQUENT 34-66% 33-200 times/day CONSTANT 67-100% >200 times/day COMMENTS

Sitting X Computer

Standing X Intermixed with walking

Walking X Primarily within work area up to 150 feet to transport materials

Kneel X

Reaching X Forward reaching

Reaching Overhead X Controls of the drum lift are overhead

Crawl X

Twist/Pivot at Waist X Weighing, mopping

Bend X

Upward Gaze X

Downward Gaze X

Squat X

Balance X

Light Grasping X

Heavy Grasping X

Fine Motor X Utensils for weighing

Foot Pedal X

Hand Controls X Hand controls on various machines and assisted lifting devices

Material Handling Details/weights of objects:

OBJECT WEIGHT FORCE HEIGHT DISTANCE FREQUENCY

Lift/Carry: Buckets (5 gallon) 3 lbs. (empty) - 12 to 35 inches 40 to 60 times per shift

35 lbs. (full - 12 to 35 inches 40 to 60 times per shift

Raw materials to room 28 to 50 lbs. - 20 to 35 feet inches 11 times in a shift

Supplies (cabinet) 15 to 25 lbs. - 9 to 88 inches Occasional

Bags of material to hatches 28 to 50 lbs. 38 inches (highest) Frequent – 40 times an hour

Trash 20 to 50 lbs. - 10 to 0 inches 1 to 2 times per shift

Skid 50 to 60 lbs. - Occasional

Push/Pull: Tote (1800 lbs. ) on hand jack - 100 lbs. of force 35 inches 150 yards 2 times per shift

• 30 to 60 lbs. 35 inches Approximately 75 feet Occasional

55 gallon drums on flat carts - 14 lbs. 35 inches 50 feet 1 to 2 times daily

55 gallon drums on hydraulic cart - 30 to 40 lbs. 35 inches 50 feet Occasional