Product Quality Engineer
About the Job
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to, the following:
Represent Quality in assigned product development and analytical method development projects ensuring compliance to Quality Management Systems (QMS) and external quality requirements in general, with a focus on Nonconformances (NCs), Change Control, CAPAs, SOPs.
Provide expertise, training, and/or consulting to internal teams in Quality processes and methods to build and maintain a customer-oriented quality culture (attending the client meetings and communicating the client needs to the site).
Establish and maintain active dialogue with partners and external customers with regards to product quality and quality assurance matters.
Host customer audits, coordinate the audit response teams, ensuring responses are delivered on time and filing the audit documentation.
May initiate and support QMS improvements and assure maintenance and continuous improvement of QMS procedures and systems within the area of responsibility.
Participate in product/process development/validation, project reviews, and relevant project meetings.
Review and approve product lifecycle design control documents and design changes.
Represent Design Control during regulatory inspections and customer audits with Development representatives.
Provide expertise, guidance, and training within area of responsibility to the organization.
Respond to customers and/or authorities' requests/inquiries dealing with regulations and product compliance.
Support Quality Assurance through writing, reviewing, and approving documentation and other duties as assigned.
This job has no managerial responsibilities. This position is eligible to perform the duties of the Quality Manager as the "Designee" if appropriately trained.
KNOWLEDGE, SKILLS, AND ABILITIES
- Demonstrated strong technical writing and communication (written and verbal) skills focused on customer service and continuous process/program improvements.
- Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and testing of drug products.
2. Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes.
3. Skill in time and priority management: must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives
4. Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations. Ability to write clear and concise reports, business correspondence, and procedures. Ability to respond to common inquiries and customer complaints and closely partner with co-workers, subordinates, and supervisors regarding product and process issues.