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 FunctionsRaw Materials and Equipment Checklist Successfully CompletedA. Obtain and weigh in products for all shiftsB. 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 only1. Assist in running validation and PPT batches.2. Assist in the training of individuals on equipment and processes.Level III only1. 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 StandardsA. 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 arecompleted 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 AvoidedA. 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 trainedC. 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 IIA. 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 functionsD. Learn to write and update SOP’s at a basic level of complexity.

Mfg. Associate IIIA. 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.

2. 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.

At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.

Invest in your own career with Mallinckrodt and let’s do something dynamic together.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)