Summary
DPS Group is seeking a Quality Operations Specialist (Clinical) to support a client in Burlington, MA. Successful candidates will Provide on-the-floor Quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues to management that may impact operations
Responsibilities

• Provide on-the-floor Quality support to manufacturing, review documentation, and make quality decisions and/or escalate issues to management that may impact operations
• Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise.
• Participate in quality oversight of manufacturing through real-time observations of activities.
• Monitor process operations to ensure compliance with specifications
• Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review.
• Identifying risks and communicating gaps for quality and GMP process/systems
• 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.
• Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations.
• Oversee and review executed electronic and paper batch record documentation.
• Support quality functional groups on as needed basis.
• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
• Perform lot disposition of Cell Bank, Plasmid, and Drug Substance
• Practice safe work habits and adhere to safety procedures and guidelines
• Other duties as assigned

Skills and Qualifications

• A minimum of 6-7 years' 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.
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
• Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
• Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
• Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
• Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
• Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
• Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
• Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.

The Company
DPS Group is a global EPCMV 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.
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