Site Compliance Manager (Bastrop, TX)
Compliance Responsibilities
- Assist the General Manager with facility management to ensure cGMP and OSHA compliance.
- Provide oversight of incoming pharmaceutical products to ensure all H&S and handling requirements are met.
- Manage the maintenance, repair, and operations of facility including infrastructure, equipment, and utilities providing facility vendor oversight as required.
- Oversee paperwork archiving to ensure compliance with regulatory and operational requirements.
- Assist the General Manage and Quality Director with managing facility-related emergencies and implement contingency plans.
- Assist the General Manager and Head of Procurement with monitoring facility budgets, optimizing costs ,and managing procurement of supplies and services.
- Assist with the filing of state and federal registration applications, permits, and/or declarations and ensure active registrations are held and maintained.
- Maintain oversight of the import, export, storage, handling, and control of Controlled Substances under DEA regulations by interpreting guidelines and ensuring internal procedures are up to date.
- Provide support to other Client departments to ensure alignment and compliance with internal SOPs, all applicable state/federal/global regulations, and support continuous training.
- Assess compliance risks in current Client processes and help develop more robust internal SOPs and training.
- Evaluate and assess training needs in collaboration with leadership and assist with the coordination and documentation of inter-department (cross) training, as needed.
- Create and deliver training programs, including classroom and digital formats, ensuring that training materials are engaging, organized, and effective.
- Develop educational resources (e.g., modules, videos, tests, and mock scenarios) and ensure that all training is documented according to company processes.
- Continuously assess and improve training content based on feedback and effectiveness.
- Support new employee onboarding to build understanding of compliance and training requirements.
- Ability to apply professional knowledge and understanding of applicable regulations/company SOPs to facilitate compliant operations for all pharmaceutical products in Client custody.
- Capability to lead communication between Client team members, clients, vendors, regulatory bodies, etc. to ensure timely delivery of project information, production records, registration renewals/updates, etc.
- Composure to liaise with client/regulatory representatives to plan and host facility visits or audits.
- Understanding of basic computer software (e.g., Microsoft Office) and ability to learn/utilize business critical applications.
- Strong organizational skills/multitasking abilities to support multiple Client projects concurrently and meet communicated deadlines.
- Strong interpersonal skills and the ability to manage, motivate, influence, and conduct compliant work behaviors in self and others.
- High level of independence and initiative, and an aptitude for attention to details, investigation, analysis, and problem solving.
- Bachelor’s degree or equivalent in life science, law, or other applicable degree.
- 4+ years’ pharmaceutical manufacturing, laboratory, or medical device experience, with knowledge of controlled substance and FDA/DEA regulations.
- 2+ years’ clinical trials supplies experience.
- 2+ years’ of project management or process improvement experience, Six Sigma experience a plus.
- Familiarity with GxP requirements and industry best practices.
Recommended Jobs
Command and Control (C2) Network Engineer
Command and Control (C2) Network Engineer Camp Pendleton South, California Secret Clearance with NATO access On-site Cyber Security Description: Maverc Technologies is seeking a …
Kitchen Manager
$20 - $25 per hour based on experience This is a Kitchen-focused position I. Executive Summary The Director of Culture & Development (Kitchen) is chiefly responsible for the performance and cul…
SPEECH THERAPIST (FT)
Job Description: Coordinates delivery of health care services to assist in diagnosis and treatment. Provides diagnostic and therapeutic patient care in Speech-Language Pathology as well as additional…
Accounting Clerk
Title: Accounting Clerk Location: Fort Worth, TX Salary: $18 - $20 / Hour Benefits: This position is eligible for medical, dental, vision, and 401(k). Job Summary: We are seeking a …
Process Engineer
Job Description Job Description Under the direction of the PDM the Process Engineer will be execute the development of the process heat and material balance, the Process Flow Diagrams defining th…
Conveyance Practice Leader and Sr. Project Manager
Why Black and Veatch Black & Veatch allows you to lend your talent and perspective to humanity’s biggest challenges in a flexible environment where you are empowered to grow and explore new possib…
Full Time Gastroenterology Job Tyler, TX
Tyler, Texas - General Gastroenterology Job ~ Clinical Role: ~ Do you know someone that might be a good fit for this position? Please ask about our generous referral fees! ~ Permanent job openin…
Cashier - $12/hour + tips- Part-Time at Shell Energy Stadium
Position Title: [[title]] Pay Range : $12.00 to $12.00 We Make Applying Easy! Want to apply to this job via text messaging? Text JOB to 75000 and search requisition ID number 1423622 .…
SAS Business Intelligence Analyst (SAS Viya) (Austin, TX)
Experience : Deep knowledge and experience developing data analysis programs in SAS Viya At least 5 years of business process visualizations, process improvement, and business system analysis. …
Junior QA Engineer
Job brief Junior QA Engineer Compensation: $60,000 - $80,000 plus equity. Comprehensive benefits package included. Minimum Experience Required: Bachelor's degree in Computer Science or a r…