Job Title

MFG Assoc I - Mon-Thurs 8:00pm - 6:15am Pay Rate - $22.65 Plus $3.00 Shift Differential and $3500 Sign-on Bonus

Requisition

JR000014516 MFG Assoc I - Mon-Thurs 8:00pm - 6:15am Pay Rate - $22.65 Plus $3.00 Shift Differential and $3500 Sign-on Bonus (Open)

Location

Hobart, NY

Additional Locations

Job Description Summary

Summary

MFG Assoc I - Mon-Thurs 8:00pm - 6:15am Pay Rate - $22.65 Plus $3.00 Shift Differential and $3500 Sign-on Bonus

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 Description

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

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.

Mfg. Associate II
A.   Preferred minimum 1 year experience as Mfg. Associate I (or equivalent related experience)
B.   Qualified Level I operator and capable of operating one additional processing technologies. (2 
processing technologies total)
C.   Willing and able to proficiently perform all level I functions
D.   Learn to write and update SOP’s at a basic level of complexity.

Mfg. Associate III
A.   Preferred minimum of three or more years’ experience in the blending department (or equivalent 
related experience) and verification of sufficient skill to perform the requirements of the 
position.  Qualified Level II operator and capable of operating two additional processing 
technologies (4 total processing technologies).
B.   Willing and able to proficiently perform all level I and II functions.
C.   May be cross trained in other department operations.
D.   Works independently with minimal supervision.
E.   Leads and promotes effective working relationships and communication in a team environment.

License(s)/Certification(s) required:
None Required

Organizational Relationship/Scope:

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 not 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:
•    Patient-Centricity – Patients and their families are at the heart of what we do.  Our decisions and our actions are guided by our commitment to improve lives.
•    Innovative – We think differently, we solve complex challenges with innovative solutions. We are agile, always seeking new ways to continuously improve our performance.
•    Collaborative - We hold ourselves and each other accountable for our shared success.  We are 
inclusive and work together towards our common goals.
•    Integrity – We do what we say we are going to do. We can be trusted to align our actions and 
our words with our mission and values.

Working Conditions:

Physical/Visual Activities or Demands:  Physical/visual activities or demands that are commonly 
associated with the performance of the functions of this job.

1.    Heavy physical demand requires frequent moving, pushing, pulling, rolling and dumping of up   
   to 100 kg and manual lifting of up to 25 kg.  Physical demand also involves walking and     
standing (70%), balancing, bending, kneeling and reaching (15%), grasping and feeling (5%) and 
communicating (10%).
2.    Mental demand is frequent requiring attention to details of specific manufacturing      
instructions and recording of information on paperwork.

3.    Visual demand is continuous and requires clarity of vision at 20 inches or less and 20 feet 
or more with peripheral vision and the ability to bring objects into sharp focus, to judge distance and space relationships and to identify and distinguish colors.

Environmental/Atmospheric Conditions: Environmental and atmospheric conditions commonly associated with the performance of the functions of this job.
1.    Exposure to pure raw materials requires incumbent to wear a respirator on a regular basis.
2.    Protective clothing and equipment including uniform shirt and slacks, jacket, safety glasses, 
  booties, hairnet, gloves, disposable respirator, hearing protection, PAPR, and tyvek suit are   
worn continuously in the performance of the job functions.
3.    Exposure to noise requires incumbent to wear hearing protection on regular basis.
4.    Work hazards include proximity to moving mechanical parts, exposure to dust, odors,      
cleaning agents, noise, and vibration.