What are the responsibilities and job description for the Quality Assurance Specialist I position at LifeScience Logistics?

Responsibilities

Reviews and approves Change Requests, Reactive Maintenance, Deviations / CAPA as assigned
Assist with validations as assigned
Review records and forms to ensure compliance with established LSL procedures and regulations
Maintain Quality files as applicable : Scan, Save to appropriate online storage, file
Perform warehouse walkthroughs to ensure the facility is maintained in a clean, safe, compliant manner
Be a part of the internal audit team and assist in external audits
Assist with the DEA program
Assist QA Supervisor and CQCU in developing plans and programs for process improvement
Interact with state and federal agencies, clients, and corporate quality group
Plan and present Quality System information to internal and external groups
Work with Quality Systems and all levels of facility personnel to achieve company quality standards
Perform Holds and Releases as directed by clients which can include template downloads as needed
Assist in the Returns, Damage and Recall processes
Review and approve inventory adjustments
Notify QA Supervisor and CQCU of any unusual trends
Perform training on Quality related documents when necessary
Other duties as assigned

Qualifications and Job Specifications

Bachelor of Science (BS) degree in Engineering, Science, or related field preferred

Minimum of 1-3 years' experience in a quality role, preferably in a logistics setting

Conversant with cGMPs, Quality Systems, and CAPAs

Strong understanding of a 3PL business, audits and complaints procedures

Medical Device, Pharma and DEA experienced preferred

Knowledge of electronic document systems

Demonstration of the following :

Effective time management skills,

Impeccable verbal and written communication skills,

Ability to conduct appropriate research as needed,

Strong presentation skills,

Attention to detail and organization,

Critical thinking, and

Interest in working in a fast-paced environment

Technical Expertise

Deftly navigate through Quality and Warehouse Management Systems with training - CQ, Tecsys Elite, WebCTRL

Intermediate Microsoft Office skills : Outlook, Excel, PowerPoint

Certified auditor training per ASQ or ISO (preferred)

Demonstrated skills and practice of Six Sigma / statistics and process capability / FMEA

Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210 / 211 and 820

Verifiable aptitude of FDA, OSHA and DEA regulations

Intermediate public speaking and presentation skills

Excellent verbal and written communication skills

Additional Employment Requirements

Must be able to successfully pass all preliminary employment requirements (ie. background check and drug screen)

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 - 50 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 length with or without correction

Working Conditions

Activities occur within a typical office environment

25% of time will be spent in a warehouse setting

15 % of time will be spent on key entry

Equipment Operated

Equipment : Laptop computer, cell phone, fax machine, copier, and desk phone

Systems : Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS - Warehouse Management System), and MQ1 (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, gender identity, or any other federal, state, or local protected class.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 60-1.35(c)

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