Quality Assurance (QA) Lead- Documentation and Product Release - (Quality)

Englewood Lab; Totowa (NJ); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance (QA) Lead to oversee compliance and documentation for product releases. In this pivotal role, you will ensure adherence to regulatory requirements while supporting audits and inspections. You will manage the Quality modules in the ERP system, lead investigations into non-conformance issues, and facilitate customer inspections. This is an exciting opportunity to contribute to a dynamic team and ensure product quality in a fast-paced environment. If you have a passion for quality assurance and a desire to make an impact, this position is perfect for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401k match

Qualifications

• Minimum of an associate or bachelor degree in Life Sciences, Engineering, or related field.
• Three or more years of industry experience in cosmetics, devices, food, or pharma.

Responsibilities

• Oversee compliance modules in ERP for change controls and deviations.
• Support investigations and corrective actions for non-conformance issues.

Skills

Data analysis

Specification development

Effective communication

Education

Associate degree

Bachelor degree in Life Sciences or Engineering

Tools

ERP system

Job description

Quality Assurance (QA) Lead - Documentation and Product Release

Title: Quality Assurance (QA) Lead - Documentation and Product Release
Reports to: Quality Assurance Supervisor or Manager
Department: Quality Assurance

Responsibilities:

• Support Annual Drug and Device History Reviews
• Oversee and maintain the Quality modules in the ERP system for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.)
• Support Investigations (e.g. non-conformance, product complaints, out-of-specification investigation) and provide corrective and preventive actions with follow-ups.
• Lead the review and release of compliance materials (e.g. FG, RM, bulk and intermediates) as required to support customer requirements.
• Maintain accurate records of approved, quarantined, rejected materials and products.
• Support audits, inspections, and ensure compliance with all SOPs and other regulatory requirements (e.g. FDA, EPA, TGA, OSHA, MFDS, ISO 22716; ISO 13485:2016).
• Maintain a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk, and finished goods.
• Participate in In-process Quality in-house and outside training programs.
• Assist in interpreting and/or developing customer specifications and requirements for approved formulas.
• Assist in establishing production and assembly inspection information sheets and documentation as required.
• Maintain and update the ERP System, maintain a repository of batch records/documents, and other Mfg & Assembly in-process specifications.
• Review batch records, work sheets, and Inspection documentation for completeness and correctness.
• Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
• Review QA Inspection reports daily for correctness and completeness.
• Facilitate on-site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control.
• Maintain awareness and compliance with safety regulations in performing job duties.
• Ensure that finished goods, bulk, raw materials, and components are maintained correctly in the warehouse and other holding areas.
• Assist in the review and release of bulk and finished products.
• Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance.
• Support formal drug stability program, bulk hold studies, and product compatibility by coordinating samples submission, testing, result retrieval, and program review.
• Maintain files and database of customer approvals and documents as evidence of authenticity.
• Effect changes to specification sheets as approved through proper change control requests.
• Support Change Control Requests for customer requested changes to raw material, intermediate/bulk, FGs, and specifications.
• Maintain copies of approved change controls as applicable to product specification updates/revisions.

Requirements:

• Minimum of an associate degree or bachelor degree (Life Sciences, Engineering, or related profession).
• Three or more years of industry or related experience in cosmetic, device, food, or pharma.
• Previous inspecting, auditing, or manufacturing experience - a plus.
• Data analysis and specification development skills.
• Computer literate and effective communication skills.

Benefits:

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match

Seniority level:

Mid-Senior level

Employment type:

Full-time

Job function:

Quality Assurance

Industries:

IT Services and IT Consulting