- Maintain a working knowledge and comprehensive understanding of FDA 21 CFR 1271, AATB standards, current Good Tissue Practices (cGTP), Good Documentation Practices (GDP), and other relevant industry standards.
- Maintain competency in knowledge of aseptic technique and sterile fields.
- Supervise production personnel and daily HCT/P production activities across morning, day, or night shift (as assigned), to include weekend overtime shifts when scheduled.
- Manufacture finished product from human tissue using aseptic technique in accordance with standard operating procedures.
- Efficiently maximize manufacturing product yield based on established production plans.
- Conduct and/or supervise execution of
- Accurately and concurrently document completion of manufacturing processes and support tasks on controlled records in accordance with good documentation practices (GDP), standard operating procedures, and regulatory requirements.
- Serve as the shift and departmental liaison in the absence of the Director of Production.
- Conduct and/or supervise sterilization of reusable supplies and related production support activities to ensure continuity of production activities.
- Support risk management of department and ensure risks/issues are identified,
- Identify and report occurrences of
- Support
- Complete self-administered read and understand training for standard operating procedures to ensure completion by assigned due dates.
- Maintain training leadership communication and hands-on skills.
- Conduct and/or supervise employee training in production procedures.
- Author, revise, and maintain procedures in accordance with FDA, AATB, and other regulations (as appropriate)
- Provide business after-hours or on-call support remotely or on-site as needed for environmental monitoring alarms, personnel issues, and/or emergency events.
- Develop and maintain relationships with key stakeholders, including vendors, customers, and employees.
- Attend scheduled training sessions as needed to develop and maintain competency for assigned responsibilities and processes, which may be scheduled outside of the normal assigned work shift based on department needs.
- Support
- Manage direct reports.
- Support
- Support
- Conduct performance reviews and support establishment of performance improvement plans as needed.
- Support
- Report to work in-person and start job duties on time for established shift or for mandatory overtime on weekdays or during the weekend as scheduled.
- Complete required hours on assigned work shifts to complete assigned responsibilities and duties properly.
- Attend all scheduled meetings and appointments.
- Perform other administrative or related duties as assigned.
- Work scheduled weekend shifts when required to support planned production or product development projects.
- Excellent attention to detail and organizational skills.
- Effective verbal and written communication skills.
- Self-motivated with the ability to work in a team environment and independently.
- Experience working with Microsoft Office (Excel, PowerPoint, Word etc.)
- Excellent documentation accuracy.
- Proficient in aseptic technique.
- Demonstrated positive, optimistic, success-oriented attitude and ability to positively support the organization, applicable policies, and management decisions.
- Ability to secure and maintain a favorable background investigation and clearance.
- High school degree or equivalent required.
- Bachelor's degree or equivalent preferred.
- CTBS Certification preferred.
- 5-7 years of hands-on aseptic or sterile environment experience required
- At least 5-7 years of experience working in an FDA regulated environment for HCT/P manufacturing
- Valid Class "C" drivers license
- Ability to push, pull or otherwise transport objects or materials weighing up to 25 lbs.
- Ability to perform job duties while seated or standing for 8-10 hours.
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Production Manager - San Antonio, United States - Extremity Care
Description
Job DescriptionJob Description Salary:
$75,000+
This position will be at both 120 Chula Vista Drive and 12000 Network Boulevard in San Antonio, TX.
Purpose:
The Production Supervisor is responsible for serving as a subject matter expert for human tissue manufacturing while supervising employees and activities on the assigned production shift.
Duties & Responsibilities:
cleaning, decontamination, maintenance, calibration, environmental monitoring and
validation/qualification
protocols.
and where appropriate, escalated.
to management and quality assurance.
and CAPA investigations as a subject matter expert.
Skills & Abilities:
Education & Experience:
Physical Requirements:
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