Accessibility Links

QC Associate 29920

  • Job reference: 931608
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Building, Construction & Infrastructure
  • Date posted: 06/08/2020

Orion Group Life Sciences have an exciting opportunity for a QC Associate for our Multinational Pharmaceutical client based in the South of Dublin area on a 12-month contract.


Job Purpose

This role will support manufacturing operations, as such some extended hours, weekend or shift work flexibility may be necessary as required.

Potential moving to a 24/7 shift Set 2021

Main Responsibilities of the role

  • With a high degree of technical flexibility, work across diverse areas within the lab
    * Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
    * Report, evaluate, back-up/archive, trend and approve analytical data.
    * Troubleshoot, solve problems and communicate with stakeholders.
    * Initiate and/or implement changes in controlled documents.
    * Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
    * Write controlled documents, perform assay validation and equipment qualification/ verification.
    * Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
    * Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
    * Approve lab results
    * May participate in lab investigations.
    * May provide technical guidance.
    * May train others.
    * May contribute to regulatory filings.
    * May represent the department/organization on various teams
    * May interact with outside resources.

Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels, Capillary Electrophoresis, pH, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.
* Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.
* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
* Take initiative to identify and drive improvements
* Excellent verbal and written communication skills
a. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
b. Presentation skills
c. Escalate issues professionally and on a timely basis
* Decision Making skills
* Teamwork and Coaching others
* Negotiation and Influence skills
* Problem solving skills
a. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
i. Ensures compliance within regulatory environment
ii. Develops solutions to technical problems of moderate complexity
iii. Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
b. Interprets generally defined practices and methods
c. Able to use statistical analysis tools to perform data trending and evaluation
* Project Management and organizational skills, including ability to follow assignments through to completion
Competencies:
* Demonstrated ability to work independently and deliver right first time results
a. Works under minimal direction
b. Work is guided by objectives of the department or assignment
i. Follows procedures
ii. Refers to technical standards, principles, theories and precedents as needed
iii. May set project timeframes and priorities based on project objectives and ongoing assignments
iv. Recognizes and escalates problems
* Demonstrated leadership and communication skills
* Auditing documentation and operation process
* Demonstrated ability to interact with regulatory agencies

Desired Experience and Background of the successful candidate

  • Bachelor's degree in a science discipline.
    * 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
    * Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.

For more information on this role, call Kate O'Sullivan on +353 (0) 212063412 or email kate.osullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 931608

#pharmaceutical #pharma #multinational #QC #GMP


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.