QC Stability Specialist

Position Summary
This position reports directly to the Sr. QC Supervisor and is primarily responsible for administrative functions related to the Real Time Stability Program. This position is responsible for ensuring studies are pulled, tested and the corresponding results are entered accordingly. This position is also responsible for any other additional tasks assigned by the Sr. QC Supervisor.

Universal Accountabilities
•    Be accountable for all meeting all assigned Quality Engineering deliverables.
•    Review notebooks, forms, and raw data. 
•    Ensure the quality of products produced at Playtex Business Unit is consistent with EPC / Playtex Mfg. Inc. Quality standards.
•    Ensure the Quality Unit is functioning efficiently by assessing current processes and identifying ways to streamline or improve.
•    Ensure the timely closure of Corrective Action Preventative Action (CAPA) investigations, ongoing investigations, and other non-conformance investigations.
•    Support appropriate product development quality related projects: internal and external.
•    Communicates effectively with internal and external customers and support groups to resolve quality issues.
•    Creates and presents reports for management, and other internal groups. Reports include trip, audit, and status.

Specific Accountabilities 
•    Performs and assists in coordinating resource allocation to conduct Stability Administration and Laboratory Administration activities to ensure accuracy and compliance against pre-defined standards and specifications.
•    Performs document control functions to ensure the integrity of all Stability and QC Laboratory records in accordance with cGMP requirements.
•    Interfaces with internal and external customers to maintain integrity of the Real Time Stability program and Laboratory Administration in conjunction with the Quality System.
•    Communicates with internal and external customers to capture and assist in resolution of quality issues and projects.
•    Tracks follow up activities associated with Real Time Stability and the QC Laboratory 
•    Collects and analyzes Stability data that will be reported to management and other internal/and external groups.
•    Review Stability notebooks and forms and QC Laboratory records prior to release to ensure that all documents meet regulatory requirements.
•    Promotes good documentation practices to everyone who records information relevant to Stability and QC Laboratory records.
•    Ensures that all OOS and non-conforming material related to Real Time Stability has been properly identified and that an OOS investigation is initiated.
•    Communicates any unexplained discrepancies or deviations to Supervisor to ensure proper investigation is conducted and documented.
•    Analyzes and interprets laboratory documentation for non-conformities.
•    Participates in Laboratory Improvement projects.
•    Performs records management and record retention activities.
•    Generates reports and metrics.
•    Responds to escalation of issues from the QC Laboratory team.
•    Responsible for ensuring a safe workplace while producing a quality product..

Required Skills and Experience
•    BA or BS degree is preferable in Biology, Chemistry, Engineering, Microbiology, or related field.
•    3 years or more of administrative experience.
•    Working knowledge of cGMPs as applicable to laboratory environment.
•    Excellent communication skills, written and verbal.
•    Problem solving skills, including root cause analysis.
•    Knowledge of basic statistics
•    Must be able to read, write, and understand English.  
•    Must be able to follow verbal and written instructions.
•    Ability to verify numbers, words, and alphanumeric combinations across multiple mediums.
•    Must be open to occasional off shift and weekend hours.
•    Ability to apply basic statistics and compare data trends.  
•    Effective verbal / written communication, interpersonal, and team-building skills.  
•    Excellent organizational, problem-solving, prioritizing and follow-up skills. 

Preferred Skills and Experience
•    SAP, Microsoft Excel, Word, Access, Autoscribe (Matrix) and SharePoint experience, preferred.
•    Ability to maintain a high level of confidentiality.
•    Must be detail oriented.
•    Good interpersonal skills
•    Strong organizational skills
•    Ability to work in a dynamic environment and be self-motivated.
•    Ability to change directions, remain flexible and respond quickly.
•    Minimum of 1-year hands-on experience supporting cGMP manufacturing environment.    
•    Minimum of 1-year hands-on experience in lab

Working Relationships
•    Reports to Sr. QC Supervisor but must work in close proximity to QC Lab Technicians and QC Chemists.
•    Ability to walk and stand for long periods of time
•    Ability to work long periods on repetitive tasks effectively
•    Comfortable in a production environment
•    Ability to lift approximately 50 pounds