Quality Assurance Supervisor - Clayton, United States - LifeScience Logistics

Description

RESPONSIBILITIES:

Manages Processes:

Change Requests, Reactive Maintenance, Deviation/CAPA.Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline.

Support Vendor Qualification programSupport 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 necessaryOther 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:
Effective time management skillsImpeccable verbal and written communication skillsAbility to conduct appropriate research as neededStrong presentation skillsStrong analytical skills for safety and complianceAttention to detail and organizationCritical thinkingInterest to work in a fast-paced environment


TECHNICAL EXPERTISE:
Navigate through Quality and Warehouse Management Systems with training - CQ, Tecsys Elite, WebCTRL

Intermediate Microsoft Office skills:
Outlook, Excel, PowerPoint.
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 REQUIREMENTSMust be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).Must be able to travel < 10%.Must have a valid driver's license.

PHYSICAL/MENTAL/VISUAL DEMANDSWork 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 efficientlyMust be able to read at a distance, close to the eyes, and at arm's lengthwith or without correctionWORKING CONDITIONSActivities occur within a typical office environment.20% of time is spent in a warehouse setting.

EQUIPMENT OPERATEDEquipment:

Laptop computer, cell phone, fax machine, copier, and desk phoneSystems: 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.

Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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)