Mallinckrodt Pharmaceuticals Operations Compliance Specialist I - 2nd Shift in Hobart, New York
Job TitleOperations Compliance Specialist I - 2nd Shift
JR000011235 Operations Compliance Specialist I - 2nd Shift (Open)
Hobart, NY (Pharma) - USA036
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. Performs trending and audits of processes/systems and takes appropriate action to correct any identified issues. Performs and leads investigations of product quality related events to determine scope of impact, corrective actions and rationale to support product disposition. Lead and assist with production safety, compliance and improvement initiatives as required. This is an independent role with progressive responsibilities. Individuals are expected to perform the necessary functions of the role with minimal oversight.
Investigations completed in a thorough and timely manner, corrective actions identified.
Lead and participate on equipment/process RCA Investigation Teams
Lead and participate on safety incident RCA Investigation Teams
Lead, investigate, write and provide support for Triages, SCARs and Customer Complaints
Lead, investigate, write and provide support for all Exceptions levels
Perform in-depth trending through Triage and Exception data to identify gaps and corrective actions
Perform risk assessments to support dispositions of Triages and Exceptions
Lead, identify, implement and execute simple and standard CAPAs
Operations compliant with Regulatory Requirements
Monitor compliance for safety requirements (I.e. PPE, fall protection, trip hazards, etc.)
Perform compliance audits for accuracy and completeness by reviewing documentation ensuring identified issues are elevated to the appropriate level
Perform Gemba Walks ensuring identified issues are escalated and corrected
Monitor and ensure compliance to procedures and policies, including coaching and mentoring operators on proper documentation
Processes and Tasks Effectively Managed, Results and Changes Managed:
Coordinate with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder
Prioritize and process work according to the production schedules; re-prioritize as schedules change
Maintain daily communication and status updates on all open items. Ensure accurate and good communication during shift turnovers
Ensure and maintain good communications with peers, production/packaging operators, supervisors, warehouse and QA
Completes all assigned tasks and documentation according to standard
Works and communicates effectively in a team environment
Identify, conduct and provide support for awareness trainings as a result of quality events, safety events, CAPAs, etc.
General Functions Performed:
Assist QA with placing lots on/off Hold due to quality events
Assist QA with lot segregations and rejections
Act as a liaison with Quality Assurance for any identified event which may potentially affect the Safety, Integrity, Strength, Purity or Quality of the product
Prepare and present presentations for MRB and CAPA
Perform Change Controls
Identify, implement and execute SOP/Form/Batch Record revisions
Lead and/or support projects as assigned by the Compliance Lead or Focus Factory
Acceptable attendance is required
Provides training and support to equal or other level positions
Performs other duties as assigned by supervision or as required by the position, including and not limited to duties of other level positions
Position Level Summary:
OCS Level 1: Has familiarity with the listed essential functions and is able to perform/apply at a basic entry level.
OCS Level 2: Displays a working knowledge of the listed essential functions and is able to perform/apply at an intermediate level. Takes initiative and lead on minor events, progressing into basic major events, for investigations, RCA, CAPAs, etc...
OCS Level 3: Knowledge of the listed essential functions and is able to perform/apply at a proficient to advanced level. Requires limited guidance and sound decision quality. Proficient in investigational writing. Takes lead on major events and performs in-depth trending, identifying deficiencies/gaps and recommends appropriate corrective actions. Progresses into complex major events, managing and leading cross-functional teams.
OCS Level 4: Requires advanced knowledge and application of listed essential functions and job levels. Can individually make complex decisions while taking into consideration quality requirements and production demands. Facilitates management and oversight of departmental functions and quality systems. Acts as mentor for quality principles, quality systems, RCA, etc. Conducts functional review and approval of triages, exceptions, change controls, forms/SOPs, batch records, protocols, etc. Leads and manages projects and cross functional teams.
Education: High School Diploma or equivalent required. Bachelor or Associates Degree preferred with equivalent combination of education, directly related experience and competencies may be considered.
Level 1: 1 to 3 years of related experience to perform the essential functions of the position within quality and quantity standards.
Level 2: 2 to 4 years of related experience to perform the essential functions of the position within quality and quantity standards
Level 3: 4 to 6 years of related experience to perform the essential functions of the position within quality and quantity standards
Level 4: 6+ years of related experience to perform the essential functions of the position within quality and quantity standards
Knowledge of cGMPs
Knowledge and understanding manufacturing and packaging instructions, processes, SOP's, etc.
Knowledge, understanding and application of quality principles
Knowledge, understanding and application of continuous improvement methods
Knowledge, understanding and application of RCA tools and methods
Knowledge, understanding and application of ANSI tables, inspections and performance of product AQL
Basic computer skills including Word, Excel and database software.
Understanding of documentation and processes for production/packaging.
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.
Perform mathematical functions of medium complexity: add, subtract, multiply and divide all units of measure, including metric.
Ability to identify and resolve people and task related issues involving non-standard situations.
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.
Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
Keeping on Point: Can quickly separate the mission-critical from the nice to do and the trivial; quickly senses what's the next most useful thing to work on; focuses on the critical few tasks that really add value and puts aside or delays the rest.
Influencing Others: Moves people toward willing involvement in a particular course of action using techniques that appeal to logic, values or emotion; presents arguments that address others' most important concerns and issues and looks for win-win solutions; involves others in a process or decision to ensure their support; identifies and proposes solutions that benefit all parties involved in a situation; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans accordingly.
Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.
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.
Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.
Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
Depending on the task, will be standing or moving majority of the day. Some tasks will require sitting at a desk performing work on a computer.
The job involves the ability to judge distance and space relationships, identify and distinguish colors and bring objects within 20 inches into clear focus.
Flow of work and character of duties involves focused mental and visual attention much or all of the time.
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.