Sr. Coordinator, Document Control (1st Shift)

Overview:

THE ROLE:

 

The 1st shift Sr. QA Document Control Coordinator will be part of the Document Control group and will work onsite at our state of art Innovation and Manufacturing facility in  Winston-Salem, NC. Is primarily responsible for the 
review, approval, and archival of Master Batch Records (MBRs); review and issuance of packaging/manufacturing  records; issuance of quality incident reports; Finished Product disposition (release / reject); and review of various batch 
related documents (RPAs, AQLs, LIRs, COAs, TDAs, QIRs, NMRs, MRRs, etc.) in regards to finished product disposition.

 

 

 

HOW YOU WOULD CONTRIBUTE:

 

• Prepare and distribute daily, weekly and monthly reports related to batch production, batch release and  department performance (e.g., monthly metric reporting, review priority email, error tracking, review turnaround-times by document type, workflow volume by document type, etc.)
• Propose, develop and work with IS teams to implement new data analysis and reporting tools
• Review and release of Production Batch Records for Packaging
• Assist other QA groups and QA management with ad-hoc data entry and data analysis requests (e.g., track  and trend)
• Review and approval/rejection of Master Batch Records (MBRs), Packaging Batch Records, Rework  Procedures (RPAs), and Document Change Requests.
• Ensure adherence with GMPs and SOPs.
• Determine disposition of finished goods and release or reject as appropriate.
• Assist management in conducting formal procedural inquiries and investigations to determine the cause of  quality problems, recommend verbal and/or written corrective actions to management as required.
• Periodically review and update SOPs to ensure they match the current processes in Document Control
• Communicating batch release needs to site management
• Interact effectively with co-workers, management and vendors in order to resolve problems.
• Assist management with the development of departmental goals and objectives.
• Performs other related duties as assigned by management.

 

 

 

WHAT’S SPECIAL ABOUT THE TEAM:

Are you ready to be part of an outstanding Document Control  team? We are seeking a highly skilled and motivated Sr Document Control Coordinator to join our dynamic group. The team is a self-directed and highly motivated group that requires minimal guidance and maintains a high level of efficiency. They are results driven and proud of the work they accomplish to prevent quality defects yet humble that they tend to stay away from the spotlight.  

 

 

 

SUPERVISORY RESPONSIBILITIES:

 

None

 

 

Job Qualifications:

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: 

 

Skills:

 

• Strong organizational and time management skills

• Good interpersonal and communication skills
• Ability to communicate effectively verbally and in written English

• Computer literacy, with proven PC and software experience managing, preserving, and providing access to digital materials.  Proficient use of MS Office, including Word and Excel.
• Ability to organize workload, prioritize responsibilities, meet deadlines and multi-task on several projects  individually as well as in a team environment
• Ability to communicate and work with other departments and groups
• Ability to lift a minimum of 45 lbs.
• Previous knowledge and understanding of Quality compliance

Experience: 

• 3+ years' experience in a GMP or another regulated environment
• 3+ years QA/QC experience
• Experience with SOPs

 

Education: 

• Associate degree in a science related area or 6 years of relevant work experience in lieu of degree.

 

PREFERRED QUALIFICATIONS:

• Previous experience working in QA documentation.
• Bachelor's degree in Technical or Science discipline
• Proficiency in Agile Product Lifecycle Management/Product quality Management
• Proficiency in Oracle R12
• Experience in Batch Record review and Final Product disposition

 

 

 

 

• The manufacturing facility is clean, orderly, properly lighted and ventilated
• Noise levels are considered low to moderate, with some areas requiring hearing protection

 

 

 

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US Benefits Statement: Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.