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Mallinckrodt Pharmaceuticals Quality Assurance Tech I in Hobart, New York

Job TitleQuality Assurance Tech I

Requisition
JR000011303 Quality Assurance Tech I (Open)

Location
Hobart, NY (Pharma) - USA036

Additional Locations

Job Description

Summary of Position
Performs review of medium complexity for all manufacturing and packaging batch records at appropriate stages in order to ensure accuracy and completeness and to reconcile at end of run. Processes and Issues labeling for the packaging of products to support the production schedules. Ensures quality procedures are followed and evaluates the organization's products, materials, and facilities for compliance. Determines if current methods and techniques result in meeting reliability standards or require modification. Takes appropriate action to correct any identified issues. Performs audits of systems and triages of product related events to evaluate and contain impact. Assists with production compliance and labeling activities as required. Depending on the department to which the incumbent reports some of the functions listed may not be applicable.

Job Results & Essential Functions

In-Process Batch Records Meet Compliance Requirements Technician I (Quality Operations Area)Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP's prior to final product release. Coordinates with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder. Assists in training operators on proper documentation. Reviews quality control checks during and after production. Ensures timely flow of records and product to next stage. Reviews equipment records and logs for completeness and accuracy when required. Maintains various reports for supervisor/manager by inputting/updating pertinent data. Maintains knowledge of cGMPs, most current manufacturing instructions, SOP's, etc. may prepare revisions as needed. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change. Assists with issuance of additional labeling (i.e. bottle labels, topserts, folding cartons, etc.) as needed. Issues additional computer generated labeling (i.e. bottle labels, carton labels, etc.) as needed. Understands and performs the task of returning unused labeling to inventory. Understands the inventory and planning systems in BPCS. Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA. Works and communicates effectively in a team environment. Continuous improvement focused and quality oriented as such is expected to participate in related activities and events. Promotes and adheres to safety requirements. Communicates any issues to the oncoming shift. Completes all assigned tasks and documentation according to standard. Performs other duties as assigned by supervision or as required by the position.

Quality Technician I (Labeling Area) Processes/releases, issues and returns all labeling based on packaging schedules. Enters SCARs for vendor defects noted during processing of labeling. Ensures timely Issuances of computer generated and commercial labeling to the Packaging department. Maintains various reports for supervisor/manager by inputting/updating pertinent data. Maintains knowledge of cGMPs, most current manufacturing instructions, SOP's, etc. may prepare revisions as needed. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change. Processes labeling returns and rejections. Reviews equipment records and logs for completeness and accuracy when required. Coordinates with operators, supervisors, team leaders, and QA to obtain information/line status. Assists in training operators on the labeling process. Ensures timely flow of records and product to next stage. Understands the inventory and planning systems in BPCS. Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA. Completes all assigned tasks and documentation according to standard. Works and communicates effectively in a team environment. Continuous improvement focused and quality oriented as such is expected to participate in related activities and events. Promotes and adheres to safety requirements. Communicates any issues to the oncoming shift. Completes all assigned tasks and documentation according to standard. Performs other duties as assigned by supervision or as required by the position.

Key Competencies
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.
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.
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:
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:
High School Diploma or equivalent required. BS or BA preferred but extensive directly related experience could be considered.

Experience:
0-2 years related experience to perform the essential functions of the position within quality and quantity standards.
Preferred Skills/Qualifications:
Ability to use Trackwise for exceptions, CAPAs, change controls and DMS.
Perform mathematical functions of medium complexity: add, subtract, multiply and divide all units of measure, including metric.
Ability to identify and address problems involving standardized situations.
Other Skills/Competencies:
* Basic computer skills including Word, Excel and database software.
Continuous improvement focused and quality oriented as such is expected to participate in and lead related activities and events.
Works and communicates effectively in a team environment.
Understanding of documentation and processes for production/packaging.
Thorough understanding of manufacturing instructions and SOP's.
Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats.
Attention to detail and accuracy.

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

(Labeling Area) Non Sedentary Work - exert periodic amount of force continuously and up to 35 pounds of force occasionally to lift or move objects. The job involves sitting, walking, standing, reaching, bending, lifting, communicating, understanding and following instructions.
(Quality Operations Area) Sedentary Work - exert a negligible amount of force continuously and up to 20 pounds of force occasionally to lift or move objects. The job involves sitting, walking, and standing, reaching, bending, communicating, understanding and following instructions.
Both areas involve clarity of vision at 20 inches or less with the ability to bring objects into sharp focus. May need the ability to identify and distinguish colors.
Flow of work and character of duties involve advanced mental and visual attention to detail much or all of the time.

Environmental/Atmospheric Conditions commonly associated with the performance of the functions of this job:

The majority of the time will be spent in the office; some time will be spent on the production floor with the potential exposure to noise and dust.


Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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