41 Quality Assurance Supervisor Jobs in Dallas, TX
LifeScience Logistics is Hiring a Quality Assurance Supervisor Near Dallas, TX
The Quality Assurance Supervisor position is responsible for the management, execution and development of all activities related to LSL’s Quality Management System ensuring products and services are compliant, safe and reliable across all LifeScience Logistics (LSL) facilities. Key responsibilities include the oversight of the document management system (electronic, hybrid and paper), internal and external audit programs, validation, and compliance with all FDA, DEA, ISO, VAWD and State Board of Pharmacy licensing requirements. This position is responsible for leading all activities pertaining to GSA functions for LSL organization. This position reports to and supports the Corporate QA Manager and manages 4 direct reports.
RESPONSIBILITIES:
- Manage change control of facilities, equipment and processes via paper and/or automated tracking system as required by cGMP. Maintain change/revision history.
- Work with Quality Systems, policies and procedures and all levels of facility personnel to achieve company quality standards and to ensure regulatory compliance.
- Administer and maintain Quality System documents – master records, SOPs, WI including filing, scanning and archiving activities, etc. Manage periodic document review activities assisting CQCU and other Functional Owners to update content and confirm training requirements.
- Help guide Operations team in determining root cause of discrepancies and help develop corrective actions and verification activities.
- Author or revise Standard Operating Procedures, Work Instructions, and training modules with Functional Owners alignment to control critical systems and ensure conformance to FDA, States, and DEA regulations, and client-specific requirements.
- Lead, Manage, and Participate in internal and external audit program, as well as developing and training new auditors.
- Participate in the validation program for new and requalification of all LSL GSA, State Stockpile, and Commercial facilities.
- Strong leadership skills and logistics (3PL) knowledge.
- Converse diligently with regulatory, State, Federal, and DEA agencies.
- Familiar in lean six sigma methodology.
- Support and assist all departments with research/investigation expertise to maintain compliance with business and regulatory needs.
- Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed.
- Collaborate with SNS Client to ensure seamless execution of Quality Systems for product and processes throughout development and product distribution phases. Lead change initiatives by identifying best approach for implementing strategic processes.
- Work with Leadership Teams for policy writing and implementation and all levels of personnel to achieve company quality standards to ensure regulatory compliance.
- Support Quality Management Review process at least twice per year.
- Direct, mentor and train direct reports to support their career goals and LSL pipeline.
- This position does not have authority to sign contracts, LSL financial obligations, other than monthly expense reporting unless delegated by VP of Quality and Compliance.
- Other duties as assigned.
- Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred).
- Minimum of 2-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry.
- A minimum of two (2) years supervisory experience – Required.
- ASQ and/or ISO Auditor Certifications preferred.
- Demonstration of the following:
- Effective time management skills
- Impeccable verbal and written communication skills
- Ability to conduct appropriate research as needed
- Strong presentation skills
- Strong analytical skills for safety and compliance
- Attention to detail and organization
- Critical thinking
- Interest to work in a fast-paced environment
- Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL.
- Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
- Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices, as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA.
- Intermediate public speaking and presentation skills.
- Ability to track and present quality metrics/trends.
- Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
- Must be able to travel up to 20%.
- Must have a valid driver’s license.
- Work is light to medium in nature with frequent walking to perform assigned tasks.
- Must be able to safely conduct occasional lifting of 20 to 50 lbs.
- Activities occur within a typical office environment.
- 10% of time is spent in a warehouse setting.
- Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
- Systems: Outlook, Excel, Word, PowerPoint, and MQ1 (Quality Management Software)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Summary
Full Time
Transportation
$110k-141k (estimate)
03/18/2023
05/18/2024
lslog.com
WHITESTOWN, IN
25 - 50
2006
RICHARD BEENY
$5M - $10M
Transportation
Related Companies
About LifeScience Logistics
LifeScience Logistics, founded in 2006, is a third party logistics company committed to offering the highest quality, flexibility, and compliance in Healthcare Supply Chain Solutions. LSL operates out of four cGMP compliant and FDA registered facilities (Atlanta, GA, Baltimore, MD, Indianapolis, IN and DFW Airport, TX) totaling more than 1.35 million SF of fully validated and temperature mapped space. Our facilities allow for Control Room Temperature (CRT) and Cold Chain Capabilities; both refrigerated (2 to 8 C) and frozen (-20 C) storage. LSL is a Board of Pharmacy licensed distributor, VAWD...-accredited, cGMP and FDA compliant company. Our can-do attitude, and efficient operations, set us apart from our competition. We pride ourselves on our ability to bring the best technology, quality, and intellectual capital to our clients. LifeScience Logistics can be found on the web at www.lslog.com. To get LifeScience Logistics news direct, visit http://www.lslog.com/News/Recent.aspx.
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The job skills required for Quality Assurance Supervisor include Quality Assurance, Leadership, Quality Management, ISO, SOP, Initiative, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Supervisor. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Supervisor. Select any job title you are interested in and start to search job requirements.
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