Manpower Engineering
Document Control Specialist - Rocky Mount, NC
Manpower Engineering, Rocky Mount, North Carolina, us, 27815
Job Title: Batch Record Specialist
Location: Rocky Mount, North Carolina
Pay Range: $20 - $25
Hours : 8 hour shift (Monday - Friday) 12pm - 8pm or 1pm - 9pm or 2pm - 10pm,
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
ROLE SUMMARY
Summarize the primary purpose and key responsibilities of the role. It may be helpful to complete this section after you have finished the other sections of the document.
The Batch Record Specialist manages the printing and assembly of production batch records based on the Materials Management manufacturing schedule for SVP (R1/R2/R3).
They are responsible for assuring accurate,complete document printing for each stage of product processing and for assuring all batch records that require tickets, labels, sample requests, stability paperwork, and additional testing requirements are included in the package.
They are responsible for communicating with Materials Management, Engineering, and Validation on list numbers that are flagged for manufacturing holds or have "manufacturing on risk" designations, which create scheduling concerns. They work closely with the department List Number Specialists to resolve/explain hold or risk issues and with Production on special printing requests
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. Identify 5 - 8 key areas that highlight accountability and level of judgement required. Ensure GMP tasks and those required by regulation are clearly documented.
Utilize systems related to batch record product, RDOCS, SAP & Batch Tracker, with Material number,Batch Number, and Product Name and any notes regarding One2One customers on the batch record footer.•
Print, assemble, and issue the production batch records based on the Materials Management production schedule, utilizing systems, RDOCS, SAP, PDOCS, and Batch Tracker, and maintain printers and paper stock.
Assign weekly production schedules and daily assignment changes to Batch Record personnel.Monitor and quickly react to schedule changes, including reworks, retrieving issued packages as necessary, and issuing the changes promptly.
Perform annual master file audits on satellite files and documents. Process storage of site documentation to off-site storage facility.
QUALIFICATIONS
Qualifications are job related, consistent with business requirements, and necessary for the performance of an essential function of this role. These include education requirements the role holder must possess, such as a Bachelors, Masters, or Doctorate degree, certifications, or other post graduate qualifications, the type and length of experience needed to perform effectively in the role, and the skills, knowledge, and attributes a candidate must possess to be competent in the position.
BASIC QUALIFICATIONS
High school diploma with at least three years' experience in controlled document management/records management, OR associate's degree with one year experience in controlled document management/records management. Thorough knowledge of cGXP. Proficiency in Documentation, Inventory and Quality Management Systems. Proficiency in Microsoft Office (Word, Excel, Powerpoint•
Ability to load printers, lift paper stock, and have at least limited ability to troubleshoot printer
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -
Manpower, Experis, Talent Solutions, and Jefferson Wells
- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Location: Rocky Mount, North Carolina
Pay Range: $20 - $25
Hours : 8 hour shift (Monday - Friday) 12pm - 8pm or 1pm - 9pm or 2pm - 10pm,
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
ROLE SUMMARY
Summarize the primary purpose and key responsibilities of the role. It may be helpful to complete this section after you have finished the other sections of the document.
The Batch Record Specialist manages the printing and assembly of production batch records based on the Materials Management manufacturing schedule for SVP (R1/R2/R3).
They are responsible for assuring accurate,complete document printing for each stage of product processing and for assuring all batch records that require tickets, labels, sample requests, stability paperwork, and additional testing requirements are included in the package.
They are responsible for communicating with Materials Management, Engineering, and Validation on list numbers that are flagged for manufacturing holds or have "manufacturing on risk" designations, which create scheduling concerns. They work closely with the department List Number Specialists to resolve/explain hold or risk issues and with Production on special printing requests
ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. Identify 5 - 8 key areas that highlight accountability and level of judgement required. Ensure GMP tasks and those required by regulation are clearly documented.
Utilize systems related to batch record product, RDOCS, SAP & Batch Tracker, with Material number,Batch Number, and Product Name and any notes regarding One2One customers on the batch record footer.•
Print, assemble, and issue the production batch records based on the Materials Management production schedule, utilizing systems, RDOCS, SAP, PDOCS, and Batch Tracker, and maintain printers and paper stock.
Assign weekly production schedules and daily assignment changes to Batch Record personnel.Monitor and quickly react to schedule changes, including reworks, retrieving issued packages as necessary, and issuing the changes promptly.
Perform annual master file audits on satellite files and documents. Process storage of site documentation to off-site storage facility.
QUALIFICATIONS
Qualifications are job related, consistent with business requirements, and necessary for the performance of an essential function of this role. These include education requirements the role holder must possess, such as a Bachelors, Masters, or Doctorate degree, certifications, or other post graduate qualifications, the type and length of experience needed to perform effectively in the role, and the skills, knowledge, and attributes a candidate must possess to be competent in the position.
BASIC QUALIFICATIONS
High school diploma with at least three years' experience in controlled document management/records management, OR associate's degree with one year experience in controlled document management/records management. Thorough knowledge of cGXP. Proficiency in Documentation, Inventory and Quality Management Systems. Proficiency in Microsoft Office (Word, Excel, Powerpoint•
Ability to load printers, lift paper stock, and have at least limited ability to troubleshoot printer
About ManpowerGroup, Parent Company of:
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -
Manpower, Experis, Talent Solutions, and Jefferson Wells
- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.