Quality System Specialist
Quality System Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Essential Duties and Responsibilities
Lead efforts in performing investigations into consumer complaints in given timeframes to prevent past due reports.
Trend consumer complaints for possible process improvements.
Generate the weekly QA Metric Report for distribution to upper management. Ensure report includes number closed number open number past due for NCMR LIR/OOS MIR planned deviations CAPAs consumer complaints and change controls.
Work with other quality system management team members to write APR reports including gathering information from various sources and ensuring that reports are complete and meet quality standards.
Manage and track the APR schedule and ensure that report due dates are met. Review the APR process for improvement to increase efficiency and ensure compliance with expectations.
Perform a statistical analysis of APR report data to identify trends. Communicate and interact with customers to resolve issues and address concerns.
Oversee Lot Traceability and Mock Recall activities including completion of quarterly lot traceability exercises annual mock recalls and lot traceability exercises as needed for audits
Facilitate the Change Control Process and apply a structured methodology and lead change management activities.
Administer Change Control Requests initiated within SCN BestCo from submission to implementation.
Lead efforts in performing change management assessments. This includes assessing any impact the change would have on existing products processes and procedures ensuring the correct subject matter experts (SMEs) are selected as reviewers of changes reviewing and assessing process and equipment changes and assessing the impact from a Quality perspective to ensure the appropriate action items are completed prior to implementing the change.
Execute final approval and implementation strategy of changes.
Maintain and complete tracking metrics of change controls. Prepare data for management review on change request trends and metrics.
Manage change control documentation through appropriate means (electronic/hard copies) and organize for easy access of records.
Maintain generate and revise applicable Standard Operating Procedures (SOPs).
Required Qualifications
Education & Experience:
Associates degree in science business administration or commensurate combination of education internships and work experience.
3 years experience working in Quality Assurance in a regulated manufacturing environment.
Knowledge Skills & Abilities (KSAs):
Proficient in Microsoft Office including Excel and Word.
Strong technical writing skills and the ability to create technical documentation.
Ability to interpret and apply Good Manufacturing Practice (GMP) regulations.
Strong organizational planning and written communication skills.
Ability to calculate figures and amounts such as proportions percentages area circumference and volume. Ability to apply concepts of basic algebra and geometry.
Ability to read and interpret documents such as safety rules operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.
Ability to apply common sense understanding to carry out instructions furnished in written oral or diagram form.
Preferred Qualifications
Knowledge of MasterControl (i.e. retrieving quality data and metrics).
Experience working in a Quality Assurance role in an FDA regulated manufacturing environment.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee is occasionally required to walk sit reach with hands and arms climb or balance taste and smell lift or carry items up to 25 pounds and push or pull items up to 10 pounds. The employee must frequently stand and use hands to finger handle or fell; and constantly required to talk and hear. Specific vision abilities required by this job include close vision distance vision color vision peripheral vision depth perception and ability to adjust focus.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually low however since this position is located within manufacturing there may be occasions where increased levels of noise and exposure to particles related to the nature of work. The position is frequently exposed to toxic or caustic chemicals.
Safety Requirements
All employees are expected to carry out their functions in a healthy and safe manner to always encourage and support safe work practices and to report and/or rectify any unsafe conditions that may come to their attention immediately. All SCN BestCo employees must wear PPE as required based on their job duties.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
