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.
• Resolve disposition of finished goods and release or reject as appropriate.
• Assist management in conducting formal procedural inquiries and investigations to identify 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
• Optimally collaborate co-workers, management and vendors in order to resolve problems.
• Assist management with the development of departmental goals and objectives. 
• Other related duties as assigned by department leader to  support and achieve team goals.

Qualifications

SUPERVISORY RESPONSIBILITIES:

None

REQUIRED QUALIFICATIONS:

Skills:

• Proficient use of MS Office, including Word and Excel
• Digital literacy, with shown PC and software experience.
• Strong organizational and time management skills, and a keen eye for detail. 
• Ability to coordinate workload, prioritize responsibilities, meet goals and multi-task on several projects individually as well as a team.
• Good interpersonal and communication skills
• effectively  communicate verbally and in written English
• Collaborate cross functionally 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 related 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

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At Herbalife, we value doing what’s right. We are proud to be an equal opportunity employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected characteristic. We value diversity, strive for inclusivity, and believe the differences among our teammates is a key contributor to Herbalife’s ongoing success.

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.

If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please email your request to [email protected].