Job description

New opportunity for a Quality Control Manager in Rockwell, NC.

Benefits Include:

• Medical
• Dental
• Vision
• STD/LTD
• Life Insurance
• AD&D
• PTO
• Holiday

Responsibilities:

The Quality Control Manager will perform their role as follows:

• Assist with the developing, implementing, maintaining and adherence of the Quality System
• Manage departmental activities in accordance with available budget, resources, and personnel
• Interviews, hires, and trains department staff
• Manage the Quality Control internal laboratory activities and analytical team
• Assist with all Regulatory and Customer inspections
• Assist with reports and other documentation as required by Regulatory agencies and Customers, including post-marketing surveillance activities such as Product Recalls
• Assist with Vendor Qualification program, including coordination of Vendor audits
• Review and approve internal laboratory testing and external contract testing laboratory reports for materials and finished products
• Review and approve Certificates of Analysis
• Prepare, review, and approve IQ/OQ/PQ Protocols/Reports for production and laboratory equipment / instruments
• Review and approve executed Process Validation, Cleaning Validation and Stability protocols/reports
• Prepare, review, and approve complaint trends and product/component failure analysis
• Prepare, review, and approve new and revised Standard Operating Procedures (SOPs) and associated Forms
• Prepare, review, and approve investigations and corrective/preventative actions (CAPA)
• Prepare, review, and approve proposed and implemented Change Controls
• Oversees and maintains the Pest Control program for site.
• Prepare, review, and approve Annual Product Reviews
• Perform additional job-related duties, as required
• Delegate responsibilities to assigned designees, as necessary

REQUIREMENTS:

• Combination of advanced degree (such as Bachelor’s or Masters in science) and 3+ years of experience in high volume manufacturing preferred
• Previous experience within a cGMP compliant facility and Quality Assurance/Quality Control preferred
• Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
• 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: $75,000.00 - $85,000.00 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:

• IQ/OQ/PQ Protocols: 5 years (Preferred)
• QC in Pharmaceutical or Nutraceutical manufacturing: 5 years (Preferred)
• FDA regulations, cGMP: 5 years (Preferred)

Work Location: In person

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