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QA Manager

Marken, a UPS Company

This is a Contract position in Aston, PA posted January 19, 2022.

About MarkenMarken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS division staffs 128 locations with 5000 employees worldwide. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial product storage and distribution. Marken’s dedicated 1200 staff members manage 90,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.*Main Duties and Responsibilities** Implement, communicate and maintain Company’s quality system and policies at the Philadelphia facility, in compliance with Marken’s Global quality management system requirements;* Effectively interact with other depot Quality members, Operations and Project Management staff and stakeholders to maintain quality and help introduce new quality improvements;* Agree standards and define quality processes and procedures throughout effective controlled document issue and management;* Liaise with clients on QA/GMP related matters;* Write quality assurance procedures as required for GMDP compliance for Marken Philadelphia CTD facility;* Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).* Prepare an external audit program and perform audits of external service providers as part of the vendor’s selection process;* Host client audits and regulatory inspections and manage the audit report responses;* Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;* Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;* Identify relevant GMDP/quality training needs and deliver training where required;* Ensure that every incoming material receipt is reviewed and released according to project study specifications;* Perform QA role in qualification and validation activities;* Coordinate any product recall as required and ensure that a mock recall is carried out on the specified period required in Marken SOPs;* Hold a monthly review of Quality at the PHL facility including metrics management and provide report to site and Global Operations management and to Global QA management;* Support the Depot/Branch Manager in carrying out an annual review of training for CTD personnel;* Ensure that relevant customer complaints are dealt with effectively;* To keep appropriate records of any delegated duties;* To participate in deciding on the final disposition of returned, rejected, recalled or falsified products, according to clients’ requests;* To ensure that any additional requirements imposed on certain products by national law are adhered to;*General** Ensure compliance with national and international standards and legislation;* Ensure timely and efficient management of records pertaining to the Quality Assurance Group;* Travel as reasonable requested by the Line Manager for the performance of duties or specific training in other facilities around Marken network;* Assist in the development and improvement of the CTD facility in PHL and to work with third party vendors in continuous development and improvement;* Undertake any other reasonable duties at the request of the Line Manager;* To adhere to all company policies at all times.*Experience** Comprehensive knowledge of Good Manufacturing Practice guidelines* Excellent written and oral communication skills.* Good interpersonal skills.* Organized, a methodical and efficient approach to work.* Proficient use of Microsoft Office.* Fluent in English* At least 5 years held position as in Quality Assurance role within a GMP regulated position.* Senior or Lead Auditor experience in self inspections, internal and external audits*Education *Educated to degree level, preferably with BSc in Pharmacy, Chemistry, or life Sciences*EEO & VETERAN Employer*Job Type: Full-timeBenefits:* 401(k)* 401(k) matching* Dental insurance* Flexible spending account* Health insurance* Health savings account* Life insurance* Paid time off* Vision insuranceSchedule:* 8 hour shiftSupplemental Pay:* Bonus payAbility to commute/relocate:* Aston, PA 19014: Reliably commute or planning to relocate before starting work (Preferred)Experience:* CAPA: 1 year (Preferred)* Quality audits: 1 year (Preferred)Work Location:* One locationWork Location: One location