Sr. Coordinator, Document Control

Overview

POSITION SUMMARY STATEMENT:The Sr. QA Document Control Coordinator works within the Document Control group and 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.

DETAILED RESPONSIBILITIES/DUTIES:• 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 turn¿around-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.• Identify disposition of finished goods and release or reject as appropriate.• Assist management in conducting formal procedural inquiries and investigations to resolve cause of quality problems, recommend verbal and/or written corrective actions to management as need emerges.• 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.

PHYSICAL DEMANDS: 

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.• Must be able to see, hear, speak and write clearly in order to communicate with employees and/or other customers.• Manual dexterity required.Sedentary: Limited activity, no lifting, limited walking Moderate: Mostly standing, walking, bending, frequent liftingLight: Office work, some lifting, considerable walking Arduous: Heavy lifting, bending, crawling, climbing

WORK ENVIRONMENT: 

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment. Positions in manufacturing facilities could involve working conditions that include the following: moving mechanical parts, working in high precarious places, fumes or airborne particles, dust, powder, toxic or caustic chemicals, strong odors and food products (milk, soy, wheat, peanuts, etc.).• The office is clean, orderly, properly lighted and ventilated• Noise levels are considered low to moderate

Job Qualifications

REQUIRED QUALIFICATIONS:Skills:• Proficient use of MS Office, including Word and Excel• Computer literacy, with solid PC and software experience.• Strong organizational skills and time management skills, detail-oriented• Ability to organize workload, prioritize responsibilities, meet deadlines and multi-task on several projects individually as well as in a team environment• Good interpersonal and communication skills• Ability to communicate optimally verbally and in written English• 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 SOPsEducation:• 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 field• Proficiency in Agile Product Lifecycle Management/Product quality Management• Proficiency in Oracle R12• Experience in Batch Record review and Final Product disposition

 

  #LI-TK1!

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.