Quality Control Associate Two Jobs in New Jersey

Location: Totowa, NJ (Onsite)
Employment Type: Full-Time | Exempt
Department: Quality Control
Reports To: Global Chief of Quality (GCQO)
Supervises: Quality Control Associates, QC Leads & Inspectors
Organizational Relationships:Contact with all areas of QA/QC personnel, Customers, Production Supervision, Warehouse, Engineering, and Operational personnel

Basic Functions:

• Scheduling of QC Inspectors to one of the following areas: (i) Bulk Mfg with Review of In-process Batch Records and related documentation and Special Sample handling, OR (ii) Production areas/Assembly lines, Warehouse FG auditing, Special Sample handling, Review of In-process Fill/Assembly Records and related documentation.
• Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups within specified area(s).
• Trains and supervises document review personnel; batch release personnel, issues certificates of conformance (COC), certificates of manufacture (COM), and certificates of analysis (COA) to customers on finished goods. Maintains accurate record of approved, quarantined, rejected products within specified area(s).
• Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
• Reviews finished goods with shipping department for formal FGs release and compliance to customer requirements.

Responsibilities:

• Work closely with Quality Assurance/Quality Systems Dept on all aspects of Quality and Compliance.
• Maintains a working knowledge of QC inspection requirements for components, raw materials, in-process/bulk and finished goods.
• Ensures that review of in-process activities in Manufacturing or Production/Assembly areas is conducted by QC inspectors for conformance to specifications; follow up on out-of-specifications including non conformances.
• Participates in In-process Quality in-house and outside training program.
• Conducts periodic analysis of In-process Inspection program and makes recommendations.
• Assist in interpreting and/or developing of customer specifications and requirements for assembly/packaging specifications.
• Assists in establishing production and assembly inspection information sheets and documentation as required
• Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Assembly in-process Specifications.
• Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness.
• Conduct non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
• Reviews of QC Inspection reports daily for correctness and completeness.
• Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed.
• Maintains awareness and compliance with safety regulations in performing job duties.
• Reviews Production and in-process related information on batch records/documents.
• Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas.
• Assist in the review and release of finished products.
• Perform supplier and vendor audits, as well as, Mock recall and internal audits
• Any additional duties of assignments as directed by the Supervisor.

Qualifications:

• Minimum of Diploma or Bachelor degree (Life Sciences, Engineering, relatedprofession)
• Five+ years industry or related experience in cosmetic, device, food, or pharma.
• Previous inspecting, auditing or manufacturing experience - a plus.
• Data analysis, specification development skills.
• Computer literate and effective communication skills.

• Onsite position based in Totowa, New Jersey.
• Monday through Friday, Full-Time.
• Additional hours may be required to support audits, inspections, regulatory submissions, and business needs.

$65,000 - $75,000 annually

Actual compensation will be determined based on experience, qualifications, skills, and internal equity. This position is also eligible for the company's discretionary bonus program.

• Medical, Dental & Vision Insurance
• Company-paid Life, AD&D and Disability Insurance
• 401(k) with Company Match
• Paid Time Off (PTO)
• Paid Company Holidays
• Special Paid Leave for Personal Events
• Employee Referral Program
• Year-End Gift
• Additional benefits as outlined in the Employee Handbook

Englewood Lab, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, pregnancy, veteran status, or any other characteristic protected by applicable federal, state, or local law. Englewood Lab provides reasonable accommodations to qualified individuals with disabilities in accordance with applicable law.