Imaging Clinical Applications Specialist, Orlando

Inteplast Group; Orlando, Miramar (FL, FL); On-site; USD 40,000 - 70,000; Full time

Job summary

Join a forward-thinking company as a Document Reviewer B, where you will play a crucial role in ensuring compliance with industry standards. This position involves auditing Batch Manufacturing Records and Packaging Records, maintaining quality documentation, and supporting internal audits. You will thrive in a dynamic environment that values attention to detail and organizational skills. If you're passionate about quality control in the nutraceutical or pharmaceutical sectors, this opportunity is perfect for you to make a meaningful impact while growing your career.

Qualifications

• 2-4 years of document control experience in a nutraceutical or pharmaceutical environment.
• Strong knowledge of cGMPs and SOPs is essential.

Responsibilities

• Review batch records and ensure compliance with SOPs and cGMPs.
• Maintain quality systems documentation and issue controlled documents.
• Assist in internal audit activities and ensure compliance.

Skills

Attention to Detail

Organizational Skills

Written Communication

Oral Communication

Math Skills

Stress Management

Education

BS/BA in Life Sciences

High School Diploma with 2 years experience

Tools

MS Office Suite

Job description

10301 Commerce Pkwy, Miramar, FL 33025, USA Req #689

Mon - Fri

8:00 AM - 4:45 PM

TITLE: Document Reviewer B

POSITION OBJECTIVE: Under supervision, conducts final audit of Batch Manufacturing Records (BMRs) and Packaging Records (PPRs). Referencing SOPs and checklists, assures that the records comply with company regulations and cGMPs. Responsible for maintaining complete and accurate records and for performing document control functions associated with Quality Control and Assurance, in compliance with cGMP's, SOP's, Federal and State Regulations, and Import/Export regulations.

QUALIFICATIONS:

• Ensure consistent, dependable attendance and demonstrate a willingness to accommodate non-standard work hours as necessary.
• Capable of effectively managing job-related stress and fostering productive workplace interactions.
• Good knowledge of math skills, excellent grammar/English/proofreading skills, good written and oral communication skills, high degree of organizational skills and attention to detail.
• BS/BA in life sciences or other closely related discipline or HS Diploma and 2 years related experience.
• Requires 2-4 years of practical document control experience in a nutraceutical or pharmaceutical environment or working knowledge of nutraceutical/pharmaceutical process.

JOB RESPONSIBILITIES:

• Review executed batch records according to production schedules, Standard Operating (SOPs) and current Good Manufacturing Practices (cGMP’s).
• Assist with the master records creation and approval.
• Maintain quality systems documentation, change control, investigation, deviations and procedures, and related records according to established processes, procedures and standards.
• Issue and track controlled documents according to established Company procedures and systems.
• Coordinate and ensure timely and accurate document flow process, including initiating routing process, revision and approval.
• Ensure all documented records and documentation is compliant with established rules, regulations, protocol, cGMP's and all other applicable standards.
• Keep trending analysis for the error encountered during the batch record review and present to the affected departments.
• Perform data retrieval, data analysis and reporting via use of information management systems and or quality management systems to report to head of department.
• Assist or perform internal audit activities, being responsible for ensuring the execution of corrective actions and ongoing compliance with the Internal Audit Program.
• Responsible to comply with all food safety and food quality programs, procedures, and policies or its references.
• Ensure that all personnel in the company apply and meet with the established controls and follow all requirements applicable to the members of the food safety team.
• Will be required to perform other duties as requested, directed or assigned.

MACHINES, TOOLS, EQUIPMENT, ELECTRONIC DEVICES & SOFTWARE:

• Proficient with MS Office Suite (Word, Excel, PowerPoint & Outlook).

Other:

• Working knowledge of Safety in the Workplace Rules and Regulations.
• Working knowledge of cGMP’s and SOP’s.

Florida Supplement is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.