Job description

Exciting Career Opportunity for an Assistant Quality Assurance Manager, located in Rockwell, NC.

The Assistant QA Manager will ensure "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. They will also prepare regular reports to upper management detailing the state of quality and systems.

Benefits include:

• Medical Insurance
• Dental
• Vision
• FSA
• Life Insurance
• Holiday Pay /Vacation Pay
• Additional perks and benefits

Responsibilities:

The Assistant QA Manager will perform their role as follows:

• Review and approve new and revised Master Batch Records
• Review and Approve of Certificate of Analyses and Certificate of Compliance
• Prepare, review, and approve investigations and corrective/preventative actions (CAPAs)
• Review and approve new and revised Standard Operating Procedures (SOPs) and associated Forms
• Review and approve internal laboratory testing and external contract testing laboratory reports for materials and finished products
• Perform laboratory testing/calibration as needed
• Perform troubleshooting for manufacturing and laboratory issues, as needed
• Implement Vendor Qualification program, including coordination of Vendor audits
• Perform additional job-related duties, as required

REQUIREMENTS:

• Combination of undergraduate degree (such as Bachelors in a science) including 3+ years of Quality Assurance or Quality Control and Regulatory experience; extensive years of experience in lieu of degree is acceptable
• Previous experience within a cGMP compliant facility and Quality Assurance/Quality Control and Regulatory required
• Ability to review labels, batch records, analytical chemistry results, product specifications and test results
• Excellent analytical and problem-solving skills
• Excellent time management and organizational skills
• Ability to work effectively in a fast-paced, rapidly changing environment
• Excellent people skills, with demonstrated ability to communicate effectively across functional groups
• Proficiency with Microsoft (MS) Office

PeopleShare provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, genetic disposition, neurodiversity, disability, veteran status, or any other protected category or class under federal, state, and/or local laws. This policy applies to all locations and all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Type: Full-time

Pay: $60,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Day shift

Experience:

• QA or QC Lead: 3 years (Preferred)
• SOP's and CAPA's: 3 years (Preferred)

Work Location: In person

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