Job description

At RxSource, our passion drives us to be the bridge between pharma and patient. With offices in Canada, USA and Ireland we provide bespoke global clinical trial supply management services to pharma, biotech and CROs. Whether it’s employing demand-led packaging, a local sourcing model or another flexible option, we guarantee on-time delivery without compromising quality. Our clients are our partners; success for them = success for us.

We currently have an opening for a Quality Assurance Manager at our New Jersey facility. This role will lead the small but growing Quality team. If you are a personable and proactive QA leader with experience in the pharma manufacturing, pharma distribution or clinical trials industry, we would like to hear from you.

What you will do:

• Lead the QA function at the New Jersey facility
• Manage all controlled GMP documents
• Initiate and handle EQMS reports (i.e. Deviation, CAPA, Change Control, etc.) reports as required
• Qualify GMP Equipment/Systems/Facilities
• Ensure all regulatory and quality-related documentation is maintained in accordance with relevant SOPs and regulatory requirements
• Plan and conduct required Quality training for all employees (i.e. GMP, SOPs, etc.)
• Provide support for customer and regulatory inspections
• Conduct supplier and customer verification/qualification and approval

Your qualifications, skills and experience include:

• 5 or more years in a QA role in pharma manufacturing or distribution or CTS
• A degree or diploma from a recognized college or university
• Experience leading and coaching a QA/QC team
• In depth knowledge of FDA and New Jersey Dept. of Health regulations and guidelines
• Knowledge of Health Canada regulations preferred
• Strong written and verbal communication skills
• Ability to prioritize
• Team player who works well with others
• A commitment to providing excellent internal and external customer service

Job Type: Full-time

Salary: $75,000.00 - $110,000.00 per year

Benefits:

• Paid time off
• Professional development assistance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Application Question(s):

• How many years experience in the pharma or clinical trial packaging industry do you have?
• What are your salary expectations?

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 3 years (Preferred)
• Quality management: 2 years (Preferred)
• FDA regulations: 2 years (Required)

Language:

• English (Required)

Work Location: One location

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