Quality Assurance Associate II - 14 Month Contract Job Openings by Septodont in Cambridge

Septodont Hiring 2021 - Septodont provide a chance to fill Quality Assurance Associate II - 14 month Contract, that will be placed in Cambridge. You will receive a better prospect as well as safer dwell later on. Becoming a member of this enterprise makes a person able to carry out the aim simpler in addition to support the current dream be realized.

To produce the corporation vision and mission happens on legitimate Septodont will be wide open on fresh placement seeing that March 2021. Everyone who are interested about staffing this vacant, please take a part in this Quality Assurance Associate II - 14 month Contract recruitment. If you will be one that may load qualifications, you can look at further info about Quality Assurance Associate II - 14 month Contract Job Openings below.

Septodont Job Vacancies 2021

Quality Assurance Associate II - 14 month Contract Job Opening in Cambridge

General information Reference 2021-465 Position description Job title

Quality Assurance Associate II14 month Contract

Job Summary

is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 1,800 people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations has facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

The company has an opening at its sterile injectable manufacturing facility in Cambridge, Ontario for a Quality Assurance Associate IICONTRACT

The Quality Assurance Associate II is accountable to the Quality Assurance Manager for all activities relating to the review of manufacturing and related documents which directly or indirectly impact batch quality in accordance with the requirements outlined in Standard Operating Procedures and Good Manufacturing Practices. This position determines final disposition of materials, i.e. releasing or rejecting, and must ensure that all corporate and governmental regulations and procedures are upheld. The Quality Assurance Associate II may also be assigned to execute activities relating to data integrity assurance (e.g. audit trail reviews).

Responsibilities

• Conducts batch record review and determination of batch status, e.g., release, reject, or product hold for further clarification or investigation. Assess potential impact of incidents and processing deviations on the quality and suitability of the product for sale.

• Reviews audit trails and other (electronic) data sources required to support batch record release.

• Investigates individually, or as a team leader or team member, Product Complaints, Deviations, ECS’s, and Out of Specification results to determine product impact, root cause and corrective / preventive actions.

• Provides oversight and QA approval to various systems (CAPA, DCR, DIR, CCR) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed.

• Assists with or oversees complaint and Pharmacovigilance system as requested by management and ensures that all adverse events and complaints are investigated and reported in a timely manner as detailed in applicable SOP’s and regulations.

• Reviews, approves and monitors progress and closure of all Change Requests.

• Reviews and approves GMP related master documentation.

• Participates in internal and external audit program as required.

• Participates in inter-departmental meetings and teams to represent the quality department interests and subsequently serve as a communication conduit to collect/distribute related information. In addition, if necessary, co-ordinates applicable activities of the quality department as appropriate.

• Participates as an active member of validation activities, both in terms of protocol approval and in review/approval of data and reports.

• Supports regulatory affairs activities as required, in the obtaining and preparation of documentation required for related filings.

• Follows GMP and regulatory requirements, and ensures quality standards are met.

• Observes and support all safety guidelines and regulations.

• Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.

• Performs other related duties as required.

Qualifications

Education

• Degree in a related science (e.g. Chemistry, Microbiology).

Experience

• Minimum of 2 years practical experience in a Quality function, or equivalent experience in a leadership role within Operations. Practical experience obtained as part of a higher degree (e.g. Ph.D.) will be considered equivalent experience, if the higher degree is in a related science.
• Experience in a pharmaceutical manufacturing environment would be an asset (cGMP).

• Ability to work independently with minimal supervision.

• Excellent verbal and written communication skills.

• Strong problem solving and decision making skills.

• Detail oriented.

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Contract duration

14 months

Contract type

ENCONTRACT

We offer

• Excellent compensation/benefits package.
• Bonus and reward programs
• Discounted gym memberships
• Programs supporting work life balance
• Employee recognition program
• Professional and personal development programs
• Social events and spirit days

Position localisation Job location

North America, Canada, Cambridge

As one of the leading companies in Canada, Septodont opens variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Septodont also gives a dynamic work environment in order to encourage employees to give optimally, and at the same time, you are able to upgrade new experience and knowing through the company programs.

If You are fascinated to send an application for Quality Assurance Associate II - 14 month Contract Jobs Cambridge March 2021 by Septodont, please prepare requirements files and documents immediately. To apply by online, please click the "Apply" button below. If you still do not satisfy with a job above, you can try to read more jobs list in Cambridge region from another company below.

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