Top 165 electronic logbook specialist Jobs

QA Batch Record Specialist - 3rd Shift
PL Developments LLC —Piedmont, SC
- Oracle
- Computer literacy
- English
- Paid holidays
- Health insurance
Truck Driver, CDL A (Part Time)
SpartanNash Associates, LLC —Saint Cloud, MN
- $0.65 per mile
- Part-time
- Computer literacy
- DOT physical examination
- Pass drug screening
- Paid parental leave
- Paid holidays
4d
Supply Chain Operations Specialist
Accelera —Portsmouth, NH
- $19.00 - $26.40 an hour
- Full-time
- Mid-level
- Forklift
- Driver's License
Quick Apply
Senior Radiation Therapist
Sunstate Medical Specialists —Lauderdale Lakes, FL
- Full-time
- CPR Certification
- 5 years
- Computer literacy
Quick Apply
4d
Truck Driver, CDL A
SpartanNash Associates, LLC —Omaha, NE
- Weekends as needed
- Computer literacy
- DOT physical examination
- Pass drug screening
3d
Administrative Assistant
Peak Performers —Syracuse, NY
- $23 an hour
- Monday to Friday
- Microsoft Excel
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
3d
Truck Driver, CDL A
SpartanNash Associates, LLC —Saint Cloud, MN
- $0.65 per mile
- Weekends as needed
- Computer literacy
- DOT physical examination
- Pass drug screening
- Paid parental leave
- Paid holidays
3d
Specialist, Quality Document Control
Rocket Pharmaceuticals —Cranbury, NJ
- $56,000 - $74,000 a year
- Full-time
- Microsoft Excel
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Field Technician
Anchor QEA —Pittsfield, MA
- $25.00 - $27.50 an hour
- Part-time
- Background check
- Clean driving record
- Construction site
Quick Apply
Per Diem Patient Care Assistant (FGP), Brooklyn Orthopedics-Bay 26th Street
NYU Langone Health —Brooklyn, NY
- $22.39 - $30.00 an hour
- Online Application
- Vital signs
- Computer literacy
- HIPAA
- Wellness program
Client Support Specialist
CURA Inc —Secaucus, NJ
- $18 - $20 an hour
- Part-time
- Organizational skills
- Entry level
Quick Apply
Data/Transport Coordinator
Kikiktagruk Inupiat Corporation —Durham, NC
- Weekends as needed
- Microsoft Word
- Mid-level
- 3 years
Quick Apply
Engagement Specialist
Homefull —Dayton, OH
- On call
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quick Apply
Medical Assistant - Commack
NYU Langone Health —Commack, NY
- $55,326.59 - $55,616.08 a year
- Online Application
- Vital signs
- HIPAA
- High school diploma or GED
- Wellness program
11d
Per Diem Medical Assistant, FGP - Huntington
NYU Langone Health —Huntington, NY
- $20 - $25 an hour
- Temporary
- Vital signs
- HIPAA
- High school diploma or GED
- Wellness program
Medical Assistant (FGP) - Rego Park, Bilingual Russian or Spanish Preferred
NYU Langone Health —Rego Park, NY
- $58,754.99 - $58,755.00 a year
- Online Application
- Vital signs
- Computer literacy
- HIPAA
- Wellness program
Lab Technician ET & Cryo
Taconic Biosciences, Inc. —Germantown, NY
- $22 - $25 an hour
- Overtime
- Writing skills
- Basic math
- Surgery
Quick Apply
Medical Assistant, FGP - Commack
NYU Langone Health —Commack, NY
- $55,326.59 - $55,616.08 a year
- Online Application
- Vital signs
- Hospital
- HIPAA
- Wellness program
11d
Document Control Specialist
NEPHRON SC, LLC —West Columbia, SC
- $3 - $10 an hour
- Overtime
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Simulator Maintenance Tech II - Moody AFB
Lockheed Martin Corporation —Moody Air Force Base, GA
- Extended hours
- Mid-level
- Windows
- In-person
- Paid jury duty
- Paid holidays

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QA Batch Record Specialist - 3rd Shift

PL Developments LLC -
Piedmont, SC

Apply Now

Job Details

Benefits

Paid holidays
Health insurance
Dental insurance
Tuition reimbursement
Paid time off
401(k) matching
Employee discount
Life insurance

Qualifications

Pharmaceutical regulatory compliance
English
Shop math
High school diploma or GED
Manufacturing standard operating procedures
Manufacturing facility
Productivity software
Safety standard operating procedures
Standard operating procedures (SOPs)
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

JOB SUMMARY:

QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release. This role is responsible for reviewing and reconciling batch documentation following production runs, including the processing of returned records and components, to ensure accuracy, completeness, and compliance prior to product release. The position also plays a key role in supporting the transition from paper-based batch records to electronic batch records (EBR), ensuring data integrity, traceability, and adherence to internal quality standards and applicable regulations.

Work schedule: Sunday - Thursday 10 pm - 6:30 am

JOB QUALIFICATIONS:

Education: High School diploma or GED required; higher learning certifications in an area relevant to role preferred.
Experience: Minimum one (1) year of experience in an FDA-regulated manufacturing facility required.
Language: Ability to read and interpret documents in the English language required.
Mathematical Skills: Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria required.
Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred.
Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines required.
Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands.
Ability to work both independently and as a member of a team.
Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums as required.
Ability to lift up to 25 pounds.
Adequate vision to read controlled documents accurately.

POSITION RESPONSIBILITIES:

Maintain professional, respectful and positive work environment.
Practice acute attention to detail, high level of organization, and error-free performance in all tasks while supporting a fast-paced environment and adapting to changing priorities to meet operations demands.
Generate controlled documents (e.g., logbooks, bulk compounding batch records, finished good batch records) for issuance using the Warehouse Management System (i.e., Oracle) and/or Quality Management System (i.e., Agile) as per the current production schedule and/or requests.
Process returns for components, Reconciliation and enter labor hours after the job is completed in production area.
Document transactions related to controlled document issuance, remittance, review, and release in shared logbooks and trackers as required.
Document metrics related to processing batch records for release in shared tracker as required.
Communicate with other departments regarding document control activities to ensure timely completion of tasks to support operations and release of finished goods.
Review controlled documents and electronic batch records (EBR), returned/submitted to Document Control for completeness and correctness to ensure compliance with internal and regulatory criteria; facilitate resolution of observations (e.g., corrections) before release of finished goods and archival of documents.
Place and remove product on QA hold when required; ensure Quality Events are resolved and verify disposition to manage bulk and finished goods accordingly.
Change product status and close jobs in Warehouse Management System for release of finished goods.
Upload required documents (e.g., batch records, customer-required documents) to appropriate shared file locations as required.
Maintain the filing system for controlled document archival and destruction as per standard processes; retrieve controlled documents as requested for inspection.
Train employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category.
Assist with batch-related investigations as requested.
Other reasonable business-related duties as necessary.

PHYSICAL REQUIREMENTS:

Ability to lift up to 25 pounds.
Adequate vision to read controlled documents accurately.

BENEFITS:
PLD is a proud equal opportunity employer offering many corporate benefits, including:

Medical and Dental Benefits

401K with employer match

Group Life Insurance

Flex Spending Accounts

Paid Time Off and Paid Holidays

Tuition Assistance

Corporate Discount Program

Opportunities to Flourish Within the Company

PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

#HP1 (https://employers.indeed.com/reporting/ads/464f974b0b0f2295?startDate=2024-01-01&endDate=2024-01-18)

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

Apply Now

Refine Your Search

electronic logbook specialist jobs

QA Batch Record Specialist - 3rd Shift

Truck Driver, CDL A (Part Time)

Supply Chain Operations Specialist

Senior Radiation Therapist

Truck Driver, CDL A

Administrative Assistant

Truck Driver, CDL A

Specialist, Quality Document Control

Field Technician

Per Diem Patient Care Assistant (FGP), Brooklyn Orthopedics-Bay 26th Street

Client Support Specialist

Data/Transport Coordinator

Engagement Specialist

Medical Assistant - Commack

Per Diem Medical Assistant, FGP - Huntington

Medical Assistant (FGP) - Rego Park, Bilingual Russian or Spanish Preferred

Lab Technician ET & Cryo

Medical Assistant, FGP - Commack

Document Control Specialist

Simulator Maintenance Tech II - Moody AFB

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