- 206692 - Batch Record Reviewer
- Industry
- MAN
- Region
- MD-Maryland
- City
- Frederick
- State
- MD
- Rate
- Up to $20.70 DOE
- Duration
- 12 Months
- Description
-
Chipton-Ross is seeking a Batch Record Reviewer for a contract opportunity in Frederick, MD.
SUMMARY:
In support of the Formulation, Fill, and Assembly Value Streams, you will work in the Manufacturing area reviewing completed batch records, forms and paperwork checking for accurate, complete, and error free entries on these documents. Data is recorded in batch records following good documentation practices as required for regulated industries.
RESPONSIBILITIES:
• Inspecting manufacturing operations for compliance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), and
• Promptly and accurately reviewing production batch records (MBRs), quality control records, and all logs to determine compliance with Good Manufacturing Practices, Good Documentation Practices, and established company procedures.
Major functions and responsibilities:
• Assemble, promptly and accurately review manufacturing batch records and daily production paperwork, and identify product records that do not meet product release requirements.
• Assist with preparing and issuing batch records for manufacturing, packaging, and labeling products.
• Assist with preparing in-process labels for manufacturing and packaging operations.
• Perform data entry activities for department databases and/or logbooks.
• Manage all production and quality control logbooks (ordering new logbooks and sending completed logbooks to document control coordinator with complete tracking record).
• Provide support during regulatory and other audit-related activities.
• Perform other duties as assigned by the Supervisor, Manager and/or Quality Systems & Regulatory Compliance Department management.
REQUIRED EXPERIENCE:
• Familiarity with Quality Assurance in manufacturing and packaging.
• Knowledge of one or more of the following is desirable: FDA regulation for a regulated industry (pharmaceutical, medical device, food products), GMPs, GDPs, and/or document control.
• Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals.
• Well-organized, detail oriented,
• Strong English language written and verbal communication,
• Basic computer skills (Microsoft Word and Excel).
• Extended hours of sitting and reading/reviewing written documents.
• Ability to occasionally work weekends and OT shifts to meet business needs.
• Ability to work in a fast-paced environment with noise and constant movement going on around you.
HARD REQUIREMENTS:
Must be able to work on third shift 10:00 pm - 6:30 am M-F.
EDUCATION:
• An Associate’s degree or at least 1 year of work experience working in a GMP environment.
WORK HOURS:
Full-Time; Third shift 10:00 pm - 6:30 am M-F. Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
- Contact
-
Amy Shook
ashook@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x206 or (800) 927-9318 x206
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.