Quality Assurance Engineer Jobs

Summary

DPS Engineering is looking for a Quality Assurance Specialist .The candidate will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in clinical and/or commercial products. This individual will work closely with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Digital and Manufacturing Science and Technology counterparts.

Key Responsibilities

• Reviews minor manufacturing deviations.
• Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.
• Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
• Oversee and review executed electronic and paper batch record documentation.
• Utilize knowledge to improve operational efficiency.
• Assist in the investigation of procedural deviations.
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
• Develop batch records, SOPs and training materials as needed.
• Closely partner with peers for rapid review of batch-related documentation.
• Monitor process operations to ensure compliance with specifications.
• Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
• Participate in quality oversight of manufacturing through real-time observations of activities.

Skills & Qualifications

• Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
• Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
• Excellent interpersonal, teamwork, and leadership skills required.
• Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
• Exceptional written, oral communication, and organizational skills required
• Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
• At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
• Effective verbal and written communication skills.

The Company

DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.