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Quality Assurance Supervisor - Durham, United States - LifeScience Logistics
Description
If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following page:Manages Processes:
Change Requests, Reactive Maintenance, Deviation/CAPA.
Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline.
Support temperature-controlled warehouse requiring scheduled on call duties (minimal).
Participate and support Internal audit program.
Assist with DEA program as applicable.
Lead interface with state, federal, ISO and LSL clients for all unannounced and/or scheduled audits at the facility.
Work with Quality systems, policies and procedures and all levels of facility personnel to achieve company standards and to ensure regulatory compliance.
Assist with Holds and Releases as directed by clients.Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed.
Lead change initiatives by identifying best approach for implementing strategic processes.Support Quality Management Review process by collecting required QA metrics and highlighting adverse trends.
This position does provide quality oversight and review of the sampling & dispensing cleanroom generated paperwork.
Perform training on Quality related documents when necessary
Other duties as assigned.
QUALIFICATIONS AND JOB SPECIFICATIONS
:
Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred).
Minimum of 3-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry.
A minimum of two (2) years supervisory experience.
Demonstration of the following:
Impeccable verbal and written communication skills
Ability to conduct appropriate research as needed
Strong analytical skills for safety and compliance
Attention to detail and organization
Critical thinking
Interest to work in a fast-paced environment
TECHNICAL EXPERTISE
:
Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL.
Strong knowledge of cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820.
Verifiable aptitude of FDA regulations.
ASQ and/or ISO Auditor Certifications preferred.
Intermediate public speaking and presentation skills.
Ability to track and present quality metrics/trends.
ADDITIONAL EMPLOYMENT REQUIREMENTS
Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
Must be able to travel
Must have a valid driver's license.
PHYSICAL/MENTAL/VISUAL DEMANDS
Work is light to medium in nature with frequent walking to perform assigned tasks.
Must be able to safely conduct occasional lifting of 25 lbs.
Ability to handle multiple priorities and solve inquiries and issues expeditiously and efficiently
Must be able to read at a distance, close to the eyes, and at arm's lengthwith or without correction
WORKING CONDITIONS
Activities occur within a typical office environment.
20% of time is spent in a warehouse setting.
EQUIPMENT OPERATED
Equipment:
Laptop computer, cell phone, fax machine, copier, and desk phone
Systems:
Outlook, Excel, Word, PowerPoint, and CQ (Quality Management Software)
LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity.
Travel RequiredYes .
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)#J-18808-Ljbffr
