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Senior Manager, Manufacturing Operations

Company: QuVa Pharma
Location: Bloomsbury
Posted on: September 20, 2022

Job Description:

Job DetailsJob LocationBloomsbury - Bloomsbury, NJPosition TypeFull TimeDescriptionPosition Overview:
The incumbent in this position has overall responsibility for sterile, potent, accurate and timely preparation, labeling, packaging and shipping of all compounded sterile products on the off shift. The primary function is to oversee all operations, site security, personnel, quality and regulatory functions of Manufacturing Operations.
The incumbent is responsible for working schedules of Manufacturing Operations. Responsible for Managing the off-shift Front Line Leadership that lead the preparation, compounding, inspection, labeling and packaging a variety of compounded drug products. Reports shift Key Performance Indicators reflecting adherence to department quality, safety, delivery, and productivity objectives. Ensures people and processes comply with safety requirements, current Good Manufacturing Practices, company policies and procedures. Modifies department standard operating procedures, investigates variances, and executes change controls to support safety, quality and productivity objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Technical Operations, and Supply Chain to meet plant objectives.
In partnership with the site leaders sponsors a safety, quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations
Responsibilities may include:
Leads in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.Oversee production activities to assure performance to plan is achievedRecognizes and sets priorities and takes prompt actionForecasts and sets goals and objectives, identifies and allocates resources as neededEffectively identifies gaps in strategy and resources and resolves themEffectively arranges for work to be completed, schedules workflow and assignments to ensure delivery performance objectives for product or projects are met or exceeded.Manages front line leadership in completion of daily operational tasks and assignmentsManages off-shift staff in execution of daily work; assures operators comply with validated parameters and standard operating procedures, cGMP regulations and safety requirements; provides constructive operator feedback.Counsels, trains, & develops front line leaders for efficient performance and assists in their career development; creates an atmosphere of team effort & open communication.Provides weekly reports to upper management addressing key accomplishments, issues and drives improvement opportunities.Supports regulatory inspections such as DEA and FDA auditsDrives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure.Completes in-process checks & verifications in alignment with Standard Operating Procedures.Reviews documentation such as batch records and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices.Develops training programs & assures training is conducted.Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications.Is consistently at work and on time; ensures work responsibilities are covered when absent and that absences are appropriately communicated and approved in advance.Other duties that may reasonably be assigned from time to time by management / supervision.This is a security-sensitive position as the incumbent will inspect, label and package-controlled substances and therefore will be subject to subject to periodic drug screen per company policy.
Qualifications:
Legally authorized to work in the job posting countryBachelors degree from recognized institution or organizationSuccessful completion of certified in-house qualification programs.10 years experience with supervision / management of up to 15/20 reports - situational leadership - multi-shift operation.Five years of prior cGMP experience with sterile products preparation Experience in FDA audits
To be considered:
In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Keywords: QuVa Pharma, Bethlehem , Senior Manager, Manufacturing Operations, Executive , Bloomsbury, Pennsylvania

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