What are the responsibilities and job description for the QA Manager position at Raise?
Position: QA Manager
We’re hiring right now; if you’re interested, apply below for your chance to join a great place to work.
Summary
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 cGMPs. Responsible for payroll review/approval, performance evaluation, promotional, and disciplinary of Quality Assurance (QA) Inspectors.
Essential Duties And Responsibilities
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.
Ability to accurately perform mathematical calculations, including:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms. The employee is required to stand, walk, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate to loud.
- Starting Range: $75000
- Location: Philadelphia, PA
We’re hiring right now; if you’re interested, apply below for your chance to join a great place to work.
Summary
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 cGMPs. Responsible for payroll review/approval, performance evaluation, promotional, and disciplinary of Quality Assurance (QA) Inspectors.
Essential Duties And Responsibilities
- 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.
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 multi- task and prioritize effectively.
- Strong critical-thinking and problem-solving skills; ability to recognize and resolve discrepancies and issues.
- Ability to apply comprehensive knowledge of cGMPs 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.
- High school diploma or equivalent.
- Knowledge of FDA and cGMPs regulations is required.
- 3-5 years of applicable experience.
- Must be able to read, understand, document and clearly communicate in the English language.
- Excellent verbal and written communication skills are required to execute documents and interact successfully with other departments.
Ability to accurately perform mathematical calculations, including:
- Addition, subtraction, multiplication and division.
- Averages, percentages and fractions.
- Ability to follow a checklist and stick to the documented procedures.
- Ability to identify problems early on and quickly determine the most effective solution.
- Skilled at knowing the right questions to ask in order to fully understand a problem or situation.
- Must be a highly organized, reliable, detail-oriented, self-starter, able to multi-task and prioritize effectively.
- Takes full responsibility for the quality of their work.
- Must be a highly organized, reliable, detail-oriented, self-starter, able to multi-task and prioritize effectively.
- Excellent listening & comprehension skills.
- Team player who is willing to go above and beyond to deliver winning service.
- Gives clear direction and instructions without being condescending.
- Remains calm under pressure.
- Able to multi-task without losing focus.
- Ability to positively adapt to change.
- Ability to get along with others.
- Must maintain a professional appearance and project a positive attitude.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms. The employee is required to stand, walk, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate to loud.
Salary : $75,000
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