Quality Assurance Manager

Overview: Quality Assurance Manager:

Manage Quality Assurance (QA) Inspectors in conducting in-process testing and quality attribute inspections to ensure products are manufactured and packaged in accordance with company policies, SOP's, and FDA cGMP’s. Responsible for payroll review/approval, performance evaluation, promotional, and disciplinary of Quality Assurance (QA) Inspectors.

Essential Duties and Responsibilities: Quality Assurance Manager:

• Manage Quality Assurance (QA) Inspectors in the day-to-day responsibilities.
• Responsible for reviewing and approving of schedule, time off, and approval of time keeping for Quality Assurance (QA) Inspectors & Supervisor.
• Conducting performance evaluations, disciplinary action, and administering policy updates/changes to Quality Assurance (QA) Inspectors.
• Ensure all activities are performed in accordance with Current Good Manufacturing Practices (cGMP) and documented in accordance with Good Documentation Practices (GDP), internal Standard Operating Procedures (SOPs) and customer specifications.
• Conduct room and line inspections for clearance prior to use.
• Verify that all materials, components and labeling issued for use are approved and acceptable for use.
• Conduct in-process testing and quality attribute inspections.
• Collect, label, document and deliver product samples for analytical testing, validation, stability, reserves, customer requests, etc.
• Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance.
• Identify and report deviations from established standards/procedures, nonconformance incidents and non-conforming materials and products to management.
• Review logbooks for accuracy and completeness.
• Apply disposition stickers to components, in-process materials and finished products.
• Perform and document component and material reconciliation activities.
• Collaborate with production and warehouse personnel to meet production requirements.
• Perform related tasks and duties may be assigned as needed.

Qualifications: Quality Assurance Manager:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Excellent organizational abilities to meet accelerated timelines, manage priorities and maximize administrative efficiencies. Superior attention to detail to ensure accuracy of work product. Ability to work on first and/or second shift, as well as overtime when required, and able to perform the physical tasks associated with sampling and inspecting.
• Must be a highly organized, reliable, detail-oriented, self-starter, able to multitask and prioritize effectively. Strong critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.
• Ability to apply comprehensive knowledge of cGMP’s and quality system controls, procedures and records to ensure ongoing quality compliance.
• Ability to perform all requirements independently with limited managerial oversight.
• Must be able to demonstrate a beginner proficiency in Microsoft Word, Excel, and Outlook.
• Ability to lead, direct, and instruct others in day-to-day responsibilities.

Education & Experience: Quality Assurance Manager:

• High school diploma or equivalent.
• Knowledge of FDA and cGMP’s regulations is required.
• 3-5 years of applicable experience.

Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.