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.
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.
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 effectively 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 SOP
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
