Quality Assurance Manager
Quality Assurance Manager
On Site Personnel
Greater Philadelphia
See who On Site Personnel has hired for this role
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.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Industrial Machinery Manufacturing and Pharmaceutical Manufacturing
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