Quality Assurance Specialist jobs in Manchester, CT

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 :

• 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 - MQ1, 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)

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)

Last updated : 2024-03-07