QC STABILITY COORDINATOR

PRIMARY PURPOSE:

The QC Stability Coordinator authors stability protocols and performs the scheduling, sample-control, documentation, testing coordination, and Quality Management System event- activities required to execute stability studies at Formulated Solutions. The position is accountable for completing assigned stability tasks accurately and on time, maintaining traceable sample inventories and study records, and escalating risks before approved pull windows, testing deadlines, or reporting commitments are missed.

The coordinator works closely with Quality Operations, Manufacturing, the Innovation and Development Group, the Quality Control Laboratory, and Quality Assurance to define study requirements, obtain required technical information and samples, coordinate testing, resolve execution issues, and maintain study timelines.

This is an individual contributor role reporting to the Stability Supervisor. The coordinator executes approved protocols and procedures and does not independently approve protocols, change study requirements, establish shelf life, disposition OOS or OOT results, release product, or supervise employees.

MAJOR DUTIES AND RESPONSIBILITIES:

Study Setup and Protocol Administration

• Author batch-specific stability protocols and protocol amendments using approved templates and applicable product, process, packaging, specification, test-method, storage-condition, and regulatory requirements.
• Route protocols and amendments to the Stability Supervisor and required cross-functional reviewers for technical review and approval before study initiation or implementation of a change.
• Resolve review comments with Quality Operations, Manufacturing, the Innovation and Development Group, the Quality Control Laboratory, and Quality Assurance and maintain traceability of required revisions and approvals.
• Create study folders, trackers, labels, pull schedules, and data-entry records from approved stability protocols.
• Assign stability study identification numbers in accordance with the approved procedure and verify that the product, lot, package configuration, storage condition, intervals, tests, specifications, and required sample quantities agree with the approved protocol.
• Calculate routine sample quantities using approved test methods and protocol requirements and submit calculations to the Stability Supervisor or designee for review.
• Identify incomplete, conflicting, or unclear protocol requirements before samples are placed on study; do not make undocumented assumptions or independently alter study requirements.
• Maintain current controlled copies of protocols, amendments, specifications, methods, and associated study records.

Sample Receipt Placement and Inventory Control

• Receive stability samples, verify identity and quantity, inspect package condition, document receipt, and reconcile discrepancies before study placement.
• Label samples and place them in the correct qualified chamber, storage condition, shelf, bin, and orientation specified by the approved protocol.
• Enter and maintain the exact chamber location and quantity for each sample in the approved inventory system or controlled tracker.
• Perform scheduled physical inventory reconciliations and document the result. Immediately escalate missing, excess, damaged, leaking, mislabeled, or incorrectly located samples.
• Maintain chain of custody for all sample movements, temporary removals, transfers, shipments, returns, and authorized destruction.
• Prepare completed or discontinued study samples for destruction only after documented authorization and reconcile quantities destroyed.

Pull Scheduling and Execution

• Maintain the approved master pull calendar and review upcoming pulls at the frequency established by procedure.
• Generate advance pull notifications and testing requests with the correct study number, lot, interval, storage condition, test panel, quantity, due date, and destination laboratory.
• Perform stability pulls within the approved pull window, independently verify the sample identity and quantity when required, and contemporaneously document the transaction.
• Deliver or ship pulled samples to the assigned QC, Microbiology, external laboratory, or other approved testing location with complete documentation and required environmental controls.
• Escalate an at-risk or missed pull to the Stability Supervisor immediately and support initiation of the applicable deviation or impact assessment.

Testing Coordination and Follow-Up

• Issue and maintain stability testing worklists that identify all required analytical, physical, and microbiological tests and their due dates.
• Coordinate testing priorities with QC, Microbiology, and approved contract laboratories and follow up until all required results and supporting records are received.
• Track samples and testing sent to external laboratories, including shipment date, receipt confirmation, testing status, report receipt, and reconciliation of returned or remaining samples.
• Compare received results against the applicable approved specification and promptly notify the Stability Supervisor of potential OOS, OOT, atypical, inconsistent, or missing results.
• Support laboratory investigations, deviations, and data requests by retrieving records and providing accurate study and sample-history information.

Cross-Functional Coordination

• Work with Quality Operations to align study execution with batch disposition, product-quality review, client commitments, deviations, change controls, and other Quality-system requirements.
• Work with Manufacturing to confirm manufacturing dates, lot details, sampling activities, package configurations, sample quantities, and timely transfer of representative stability samples.
• Work with the Innovation and Development Group to obtain formulation, process, packaging, development-study, method, and technical information needed to author and execute stability protocols.
• Work with the Quality Control Laboratory to confirm test requirements, methods, specifications, sample quantities, laboratory capacity, testing schedules, and completion of stability testing.
• Work with Quality Assurance to obtain protocol and amendment approval, address compliance issues, support investigations and changes, and ensure stability records are complete and inspection-ready.
• Maintain action items, owners, and due dates resulting from cross-functional stability discussions and escalate unresolved issues to the Stability Supervisor.

Data Entry Records and Reporting

• Enter stability results into the approved system or controlled data table and perform a documented verification against the original approved result.
• Maintain complete study files containing the current protocol, amendments, pull records, testing requests, raw-data references, approved results, investigations, deviations, correspondence, and reports.
• Prepare draft data tables, graphs, summaries, status reports, and study closeout packages for technical review and approval by authorized personnel.
• Reconcile each interval to confirm that every required test has a result or documented explanation before routing the interval or study for review.
• Archive completed study records and supporting documentation in accordance with record-retention and document-control requirements.

Chamber Monitoring and Excursion Response

• Review chamber monitoring records and alarm status at the frequency required by procedure and document completion.
• Immediately notify the Stability Supervisor and designated Facilities, Metrology, Maintenance, and Quality representatives of alarms, excursions, power interruptions, or chamber failures.
• Support controlled sample transfers during chamber events and maintain traceable records of sample location, time out of condition, and return or relocation.
• Provide sample inventories and study details needed for excursion impact assessments and investigations.

Documentation and Compliance

• Perform all activities in accordance with cGMP, approved procedures, protocols, specifications, data-integrity requirements, and applicable client commitments.
• Create records that are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
• Initiate and author stability-related events in the approved Quality Management System, including deviations and other assigned Quality events. Ensure event descriptions, chronology, immediate actions, supporting evidence, product or study impact, and assigned follow-up actions are accurate, complete, understandable, and entered within required timelines.
• Support change controls, CAPAs, OOS or OOT investigations, and laboratory investigations as assigned; complete assigned actions by the established due date.
• Assist with SOP, work-instruction, form, and protocol revisions by providing accurate process information and completing assigned document tasks.
• Retrieve stability records and samples for audits, inspections, regulatory submissions, client requests, and APR or PQR activities.
• Complete required training before independently performing assigned tasks and maintain qualification on applicable procedures and systems.
• Perform other duties as assigned within the employee's training and authorization.

REQUIRED DELIVERABLES:

• An accurate, current master stability pull schedule with no unreported missed pull windows.
• Complete and technically accurate stability protocols and amendments authored and routed for review and approval by assigned due dates.
• Pull notifications, sample pulls, transfers, and testing requests completed within approved timelines.
• A reconciled physical and electronic stability sample inventory with each sample traceable to its study, condition, location, and quantity.
• Complete interval files with all required results, investigations, deviations, and supporting documentation accounted for.
• Current testing status and external laboratory trackers with overdue items identified and escalated.
• Draft stability data tables, graphs, summaries, and closeout packages prepared by assigned due dates.
• Documented chamber reviews, inventory checks, discrepancy follow-up, and timely escalation of excursions or alarms.
• Stability-related QMS events initiated promptly, authored completely, and advanced through the required workflow within established due dates.
• Weekly or other assigned status updates to the Stability Supervisor covering upcoming pulls, testing risks, inventory discrepancies, investigations, and overdue actions.

QUALIFICATIONS:

Required:

• Working knowledge of cGMP documentation practices and data-integrity principles.
• Ability to follow approved protocols, SOPs, test methods, specifications, and controlled forms without unauthorized changes.
• Ability to author clear, technically accurate stability protocols, protocol amendments, and QMS event records using approved templates and source information.
• Strong attention to detail and ability to maintain accurate schedules, inventories, and records across multiple active studies.
• Ability to identify discrepancies and escalate product-quality or compliance risks promptly.
• Effective written and verbal communication and cross-functional follow-up skills.
• Proficiency with Microsoft Word and Outlook and intermediate Microsoft Excel skills; ability to learn laboratory and quality systems.
• Ability to work independently on assigned tasks while recognizing decisions that require supervisor or Quality approval.
• At least one year of experience in a cGMP laboratory, pharmaceutical manufacturing, stability, sample-control, or Quality environment.

EDUCATION AND EXPERIENCE:

• Associate degree in Chemistry, Biology, Pharmaceutical Sciences, or a related discipline is preferred. A high school diploma or equivalent with directly relevant cGMP experience may be considered.
• One to three years of experience in a cGMP-regulated laboratory, stability, sample-management, or pharmaceutical manufacturing environment is preferred.
• Experience with stability chambers, controlled sample inventories, LIMS or electronic Quality systems, contract laboratories, or ICH stability requirements is preferred.
• Experience using MasterControl QMS to initiate, author, route, and track deviations or other Quality events is desirable.