Collect Batch tickets, batch pull tickets, Production fill tickets, quality documentation from respective departments and build the batch record folder for every lot of product produced at Dallas One Solutions.
Review the documentation for good documentation practices and interface with appropriate staff to resolve questions, inconsistencies, or missing data.
Maintain and update the Batch record status log on the company public drive “P” so all team members have visibility to the pending documents.
Perform the first review of the batch record and turn in the completed batch records to the Document Control Specialists team.
Assist Document Control Specialist team in creating Certificate of Analysis (CoAs).
Assist in the implementation of Change control and Deviation program
Other duties or responsibilities may be required as needed.
Education
A minimum of high school diploma is required.
Basic math skills.
Ability to work effectively in a team environment.
Detail oriented with a critical eye.
Strong organizational skills.
Legible charting and documentation skills.
Proficient with Microsoft Office Programs.
Knowledge and have experience using the ERP system.
Basic knowledge of cGMP and dietary supplement/food regulations.
Experience in food or dietary supplement manufacturing is ideal.
Excellent grammatical and spelling skills.
Versatility, flexibility, and a willingness to work within constantly changing priorities.
Demonstrated ability to plan and organize projects.
Ability to work independently and self motivated.
Ability to multitask.
Ability to work in a fast paced environment
Competencies
Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Design’s workflows and procedures.
Technical Skills--Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Customer Service--Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
Interpersonal Skills--Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Oral Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication--Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork--Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. .
Quality Management--Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Physical Demands And Work Environment
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. The employee is frequently required to stand; walk; use hands/fingers to handle or feel; reach with hands and arms and talk or hear. The employee must regularly lift/move up to 25 pounds. May work in warehouse/production environment as well as office area.
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