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Production Assistant Processing

Location:
Greenville, NC
Salary:
Negotiable
Posted:
January 29, 2023

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Resume:

Demita Farrow

Clinical

Greenville, NC *****

adu0kr@r.postjobfree.com

+1-252-***-****

• Experienced Processing Assistant with a demonstrated history of working in Healthcare and Pharmaceutical Industries.

• Experience in clinical research, cell production, Healthcare administration, nursing and blood and Lab collection.

Authorized to work in the US for any employer

Work Experience

Formulation Technician II

Thermo Fisher Scientific - Greenville, NC

February 2022 to Present

• Maintain required cleanliness for equipment, work areas and facility.

• Prepare manufacturing suites and components for Production Batch Record execution.

• Execute Production Batch Records to make pharmaceutical products.

• Operate in a safe manner, wearing appropriate PPE, identifying and notifying of any safety hazards.

• Follow established waste disposal operations.

• Perform all duties in a manner consistent with cGMP (current Good Manufacturing Practice).

• Follow all appropriate SOPs, Good Documentation Practices and Data Integrity procedures.

• Exhibit Thermo Fisher’s 4i Values (Integrity, Intensity, Innovation and Involvement).

• Performs other vital technician responsibilities as directed. 1. Maintained adequate inventories of all materials to ensure no interruptions in production processes. 2. Completed documentation related to production processes, following GMP/GLP practices. 3. Assisted with changes to SOPs and related controlled documentation. 4. Assisted to maintain inventories through the use of materials management systems. 5. Helped with data collection for investigations. 6. Ensured processes are in control, and provided timely and constructive feedback to peers, support groups, and manager.

Formulation Technician III

Thermo Fisher Scientific - Greenville, NC

February 2021 to Present

• Maintain required cleanliness for equipment, work areas and facility.

• Prepare manufacturing suites and components for Production Batch Record execution.

• Execute Production Batch Records to make pharmaceutical products.

• Operate in a safe manner, wearing appropriate PPE, identifying and notifying of any safety hazards.

• Follow established waste disposal operations.

• Perform all duties in a manner consistent with cGMP (current Good Manufacturing Practice).

• Follow all appropriate SOPs, Good Documentation Practices and Data Integrity procedures.

• Exhibit Thermo Fisher’s 4i Values (Integrity, Intensity, Innovation and Involvement).

• Performs other vital technician responsibilities as directed. Cell processor/Biotechnology

Dendreon Pharmaceutical - Union City, GA

May 2017 to July 2021

Phlebotomist

• Labeling all Apheresis samples, samples tubes, and separation containers.

• Decipher the best method for drawing blood depending on the specific patient.

• Maintain records and clean room environment to comply with regulatory requirements.

• Good manufacturing practices and aseptic processing of clinical and commercial products using Standard Operating Procedures

• Review, batch records and logbooks to ensure accuracy and completeness prior to QA final review.

• Investigate deviations to determine impact, root cause, and corrective measures.

• Compose and submit reports (i.e. shift report, schedule, etc.) throughout department and upper management team.

• Sending all final products to the appropriate designation.

• Conduct site equipment inspection and site SOP to ensure patient safety and adherence to protocol.

• Ensure site is adhering to protocol and abiding by the inclusion and exclusion criteria as stated in the protocol. Obtain consents, signature and other required documentation.

• Meet the quality and quantity production goals established by the department.

• Maintains records and clean room environment to comply with regulatory requirements, good manufacturing practices and aseptic processing of clinical and commercial products using standard operating procedures (SOP).

Collection Technician/Phlebotomist

American Red Cross - Atlanta, GA

March 2009 to February 2017

• In my position I performed a variety of the technical procedures involved in the procurement.

• Processing and evaluation of patient specimens for use in the diagnosis and treatment of disease; teach and perform routine clerical and technical procedures including specimen collection.

• Responsible for the delivery of supplies and procurement of specimens from physicians? offices, clinical specimen preparation and processing for analysis and dispatch, patient registration and order entry; and serve as hospital laboratory representative and liaison with outside clients.

• Perform a variety of routine and specialized procedures.

• Prepare and initiate special tests and procedures including, but not limited

• Communicate in a professional and courteous manner with patients, family and other medical personnel as necessary for problem recognition and initiation of the resolution and, if necessary, escalation to the next level.

• Obtain information for laboratory records, explain procedures, allay fears and elicit cooperation.

• Perform a variety of routine and specialized specimen preparation procedures including, but not limited to, general laboratory specimen preparation, cytology specimen preparation, cytogenetics specimen preparation.

• Perform various quality control, safety, and infection control procedures to maintain compliance with internal and external regulations.

• Received and process specimens as required by respective laboratory area procedures and protocols.

• Participate in the distribution of specimens, supplies and reports to the appropriate laboratory staff.

• Maintain inventory of supplies; stock supplies on carts and hand trays; wash glassware. Production Assistant

Osmotica Pharmaceuticals Corp - Atlanta, GA

February 2002 to March 2009

Production Tech

• Responsible for manufacturing of cGMP products, following SOP's and providing accurate documentation in production batch records.

• Operates automated and semi-automated equipment.

• Prepares materials and equipment for production.

• Supports equipment cleaning verification and validation activities.

• Troubleshoots initial mechanical issues to resolve problem before contacting support services

• Core Competencies.

• Ability to work in a regulated environment (GMP, FDA, DEA, OSHA)

• Ability to read, write and comprehend reports, technical and cGMP documents Strong attention to detail

• A team player with a positive attitude and able to take initiative.

• Ability to compute mathematical calculations and conversions.

• Superior attention to detail, safety, and quality is critical.

• Ability to multitask is required

Supervisor of Pediatric Cardiology

Brody School of Medicine, East Carolina University February 1998 to January 2002

• Responsible for developing and implementing the clinic's mission and strategic vision.

• Provides leadership in developing planning and implementing the clinic's business plans to the Physicians.

• Recommends, develops, implements improvements for the practice.

• Informs board about current trends, problems and medical activities to facilitate policy making.

• Establishes, secures approval and overseas clinic operating policies and procedures.

• Oversees efforts for recruitment, development, performance evaluation of employees.

• Oversees the business and financial affairs of the clinic and fiscal management in conjunction with the practice CPA.

• Coordinates with the billing and collection processes/department.

• Enhances operational effectiveness, emphasizing cost containment without jeopardizing important innovation or quality of care.

• Ensures clinic compliance with all regulatory agencies governing health care delivery and the rules of accrediting bodies. Continually monitors operations, programs, physical properties. Initiates appropriate changes.

• Represents the clinic in its relationships with other health organizations, government agencies, and third-party payers.

• Serves as liaison and channel of communication between the hospitals, health plans, insurance companies and regulatory bodies.

• Resolves any medical-administrative problems and keeps lines of communication open with staff to ensure high employee morale and a professional, healthful clinic atmosphere. Education

Bachelor of business Administration in business Administration American Intercontinental University Online

April 2011 to 2015

Nursing

Middlesex Community College Jan

Skills

• Aseptic

• Cell Culture

• GMP

• Biology



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