Job description

Job Title: Quality Assurance Manager

Job Type: Full-time direct hire

Job Location: Hamilton, NJ (On-site)

Salary: DoE

Work Authorisation: US Citizen/GC

Prefer local candidates. Would consider out of the area if exceptional

Job Description

The position will be involved in overseeing and executing Quality functions related to FDA and ISO 17025 compliance, and supporting growth of the quality system as the company expands into additional regulated areas.

Primary Responsibilities:

· Develop, maintain, and improve the IAS quality system for compliance with applicable regulations

· Manage day-to-day quality functions including oversight of Archives

· Manage archives and ensure all SOPs and training materials are following GLP requirements

· Develop and implement QMS procedures to lead and set a strategy for GLP functions to ensure compliance and data integrity (e.g., records and data per 21CFR Part 58).

· Develop and coordinate training requirements for company employees

· Oversee change control for computer systems, equipment, and documents

· Write, review, and approve SOPs related to company systems, including Facilities and Equipment, Laboratory Control, and Quality

· Oversee OOS and OOT investigations, deviations, CAPAs, and customer complaints

· Issue, review and approve regulated documentation, including study/validation protocols, SOPs, laboratory records and data, inspection records and study/validation reports

· Perform and document internal audits for compliance to applicable regulations and IAS policies and procedures; report quality system performance metrics to management

· Host regulatory and client audits, respond to audit findings, initiate CAPAs, and prepare response reports

· Participate in project management meetings to stay abreast of current company projects and advise management on areas of regulatory / business risks related to compliance activities

· Stay abreast of current best practices, industry standards and regulations in the pharmaceutical industry

Qualifications:

Looking for a self-motivated individual who values working in a team environment and contributing to projects in a fast-paced entrepreneurial setting that focuses on quality and efficiency. Must be able to manage tasks with competing priorities or deadlines, and have a willingness to take on additional responsibilities to support corporate and project efforts. Demonstrated ability in sound judgement and working independently with minimal supervision and/or guidance. Ability to understand and implement written and verbal instructions to all levels of the organization. Minimum 3 years of QA experience in pharmaceuticals, biologics, medical devices or an equivalent regulated (FDA or ISO) compliant environment. Experience with ISO 17025 a plus. Strong written and computer skills are a must.

Job Type: Full-time

Experience:

· Regulations: 3 years (Required)

Job Type: Full-time

Salary: $50,112.70 - $120,000.00 per year

Benefits:

• 401(k) matching
• Health insurance
• Life insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Township of Hamilton, NJ 08641: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)

Work Location: One location

Speak with the employer
+91 +13022164931

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