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Manufacturing Associate I

4 months ago

Hobart, United States Mallinckrodt Pharmaceuticals Full time

Description

Summary of Position
Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities.

Job Results & Essential Functions

Raw Materials and Equipment Checklist Successfully Completed
A. Obtain and weigh in products for all shifts
B. Moves raw materials and product to/from vault, cage, process or storage areas.
C. Inspects machine parts for unusual wear and proper lubrication.
D. Operates equipment required in the manufacture of pharmaceutical product.
E. Performs/reviews quality checks on weight, thickness, hardness and friability of tablets at various stages of the process according to manufacturing instructions and SOPs.
F. Submits product samples to quality laboratories as required.
G. Maintains product batch, room activity, and equipment records.
H. Maintains control of DEA scheduled material in accordance with accepted policy, practice and procedure.
Level II and III only
1. Assist in running validation and PPT batches.
2. Assist in the training of individuals on equipment and processes.
Level III only
1. Run Validation and PPT batches.
2. Write and update SOP’s of medium level of complexity.
3. Review new and/or updated batch records.


Work Center Schedule and Shift Attainment Achieved to Standards
A. Is at his/her position on the line ready to start production as required.
B. Monitors the production process, makes periodic checks and adjusts equipment or work practices to maximize production efficiency, yields, quality and safety. Accurately reports production and ensures reports are completed as required.
C. Performs operator-level machine adjustments and lubrication. Assists technicians with minor machine repairs and set-up.
D. Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production.
E. Ensures that line conditions are acceptable to change from one product to another by ensuring that materials, paperwork, and equipment have been staged for changeover.

Downtime Avoided
A. Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns.
B. Documents inspections performed and keeps accurate equipment records, clean-up sheets and other required paperwork.
C. Disassembles, cleans and reassembles basic line equipment according to SOPs. Insures proper inspections are conducted prior to reassembly.
D. Cleans and assembles dust collector.
E. Assists in the training of individuals on equipment and processes in the department.

Compliance Standards Met
A. Follows all EHS rules and regulations. Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured.
B. Complies with all site security requirements.
C. Performs lock-out/tag-out procedures according to SOPs.
D. Follows safe working practices in the execution of their assigned duties.
E. Collects all process related hazardous wastes and transports to accumulation drums.
F. Actively participates in general site and departmental Safety initiatives.
G. Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies.

Escalation Process Adhered to
A. Makes initial attempts to identify root cause within scope of decision-making authority while simultaneously notifying next level of leadership.
B. If attempts at the next level do not resolve the problem and the Associate believes that a higher level needs to be involved, the problem is escalated to the highest level.

Marginal Functions
A. Assists technicians at other stations within the department as needed.
B. Works on any tableting stations on which you are trained
C. May be crossed-trained in other functions


Competencies
Problem Solving: Rigorously and systematically connects information, processes and events by organizing divergent information and searching for common themes, patterns, and causal connections. Undertakes a complex task by breaking it down into manageable parts in a systematic, detailed way. Thinks of several possible explanations or alternatives for a situation and anticipates potential obstacles and develops contingency plans to overcome them. Uses intelligence, common sense, hard work and tenacity to solve particularly difficult or complicated challenges.
Attention to Detail/Focus: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently. Double-checks the accuracy of information and work product to provide accurate and consistent work. Provides information on a timely basis and in a usable form to others who need to act on it. Compares observations of finished work to what is expected to find inconsistencies.
Follows Processes Consistently: Shows concern for all aspects of the job by accurately checking processes and tasks; carefully and accurately follows established procedures for completing work tasks; uses knowledge that is acquired through formal training or extensive on-the-job experience to perform one’s job.
Composure: Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted onto hold things together during tough times; can handle stress; is knocked off balance by the unexpected; doesn’t show frustration when resisted or blocked; is a settling influence in a crisis.
Positive Attitude/Engagement: Shows commitment/dedication and accountability in one’s work; and follows through on all aspects. Takes personal responsibility for resolving problems brought to one’s attention. Goes beyond expectations in the assignment/task, or job description without being asked.
Incorporates Mallinckrodt Cultural Hallmarks in daily routine:
• Accountable: Promote responsibility. Forward thinking to anticipate potential issues and downtime.
• Competitive: Continuous improvement oriented. Understand, promote, and practice lean principals.
• Collaborative: Excellent written and verbal communication skills, ensuring professional and courteous interactions at all organizational levels. Work effectively in a high performing team environment; understand the basic concepts of team dynamics and team building.
• High Performing: Understand and support performance excellence objectives.
• Trustworthy

Minimum Requirements
Education:
Requires the basic knowledge and ability to apply mathematical concepts, spelling, reading English, and grammar. Requires a High School diploma or GED.

Experience:
Recommended minimum of three to twelve months’ experience under direct supervision and guidance in order to gain sufficient skill to perform the requirements of the position. 

License(s)/Certification(s) required:
None Required
Preferred Skills/Competencies that may be representative but not all inclusive of those commonly associated with this position:
A. Ability to comprehend and carry out instructions furnished in written and oral form and deal with problems involving standardized situations.
B. Must be willing and able to learn to learn to operate and set up manufacturing equipment (dispensing, blending and tableting equipment) and follow SOPs, cGMP and manufacturing instructions. 
C. Perform the basic functions of arithmetic; add, subtract, multiply and divide all units of measure.
D. Perform reading, writing and speaking at a basic level.
E. Ability to work under direct supervision to learn the functions of the position.
F. Basic eye-hand coordination. 
G. Capability of operating manufacturing equipment
H. Accuracy and attention to detail are critical
Machines, Tools, Equipment, Work Aids that may be representative but not all inclusive of those commonly associated with this position (see Department Training Manual for most current and comprehensive list of equipment):
PH300, XL200, XL-400, XL800 tablet presses; 60” coater, 48” coater; Zanasi encapsulators; capsule weight sorters; tablet imprinter; automated inspection equipment; changeover Support.


Physical Demands/Work Environment
Physical/Visual Activities or Demands that are commonly associated with the performance of the functions of this job:
A. Medium physical demand requires continuous scooping, dumping, lifting or moving of 5 to 45 kg and frequent moving, pushing, pulling and rolling of up to 100 kg. Physical demand also involves standing/walking, reaching and grasping (75%) and stooping, crouching and sitting.
B. Mental demand requires frequent attention to multiple, repetitive aspects of the tableting process as well as to the details of specific manufacturing instructions, verification of product integrity and recording of information on paperwork.
C. Visual demand is continuous and requires good hand/eye coordination, clarity of vision at 20 inches or less and the ability to bring objects into sharp focus, to identify and distinguish colors, to handle small parts and visually inspect the product for quality standards. 

Environmental/Atmospheric Conditions commonly associated with the performance of the functions of this job:
1. Exposure to active materials requires incumbent to wear a respirator/mask on a regular basis.
2. Protective clothing including shirt, slacks, safety glasses, booties, hairnet and gloves are worn continuously in performance of the job functions.
3. Work hazards include proximity to moving mechanical equipment, exposure to active powder ingredients and dust, odors, cleaning solvents, noise, vibration and poor ventilation.