![DPS Group Global](https://media.trabajo.org/img/noimg.jpg)
Senior Quality Assurance Specialist
3 months ago
Summary
DPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.
Responsibilities
- Perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA site.
- This quality oversight is of all the Quality Control and Facility groups. The major sub-teams supported are: Manufacturing, MS&T, Supply Chain, Facilities, Quality Control
- Oversee and review executed electronic and paper batch record documentation.
- Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
- Closely partner with peers for rapid review of batch-related documentation.
- 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.
- Monitor process operations to ensure compliance with specifications.
- Assist in the investigation of procedural deviations.
- Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
- Reviews minor manufacturing deviations.
- Develop batch records, SOPs and training materials as needed.
- Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.
- Utilize knowledge to improve operational efficiency.
- Participate in quality oversight of manufacturing through real-time observations of activities.
- Other duties as assigned
Skills and Qualifications
- 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.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
- Exceptional written, oral communication, and organizational skills required
- Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
- Effective verbal and written communication skills.
- Excellent interpersonal, teamwork, and leadership skills required.
- Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
- 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.
-
Quality Assurance Specialist
2 weeks ago
Boston, Massachusetts, United States Arcaea Full timeArcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering...
-
Quality Assurance Specialist
3 months ago
Boston, United States Arcaea Full timeJob DescriptionJob DescriptionArcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in...
-
Quality Assurance Specialist
5 days ago
Boston, Massachusetts, United States RQMIS Inc Full timeJob OverviewRQMIS, Inc. is on the lookout for a Quality Assurance Specialist who will play a pivotal role in our team. This position is focused on working closely with consultants to manage projects that pertain to regulatory submissions, quality management documentation, and clinical research materials.Core Responsibilities:Assist clients in the design and...
-
Senior Quality Assurance Specialist
2 months ago
Boston, United States DPS Group Global Full timeSummaryDPS Group is seeking a qualified Senior Quality Assurance Operations professional to perform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA client site.ResponsibilitiesPerform batch disposition, batch record review, deviation, CAPA and change control support at the Boston, MA site.This quality...
-
Senior Quality Assurance Engineer
5 days ago
Boston, Massachusetts, United States Stellar Elements Full timeJob OverviewAt Stellar Elements, we pride ourselves on being advocates for exceptional experiences.Our mission revolves around enhancing customer, employee, and brand interactions by bridging the gap between organizational objectives and genuine human needs. This endeavor requires dedicated problem-solvers, innovative thinkers, and individuals with profound...
-
Software Quality Assurance Specialist
4 days ago
Boston, Massachusetts, United States Overture Partners Full timeAt Overture Partners, we pride ourselves on being pioneers in the realm of software development, recognized for delivering innovative and high-quality software solutions. Our commitment lies in creating products that meet the highest standards of functionality, reliability, and user satisfaction. We value precision, thoroughness, and a relentless pursuit of...
-
Software Quality Assurance Specialist
5 days ago
Boston, Massachusetts, United States Overture Partners Full timeAt Overture Partners, we pride ourselves on being at the forefront of software innovation, recognized for delivering exceptional and creative software solutions. Our focus is on developing products that meet the highest standards of functionality, reliability, and user satisfaction. Our team values accuracy, thoroughness, and a commitment to excellence in...
-
Senior Quality Assurance Engineer
4 weeks ago
Boston, United States Finance Full timeQuality Assurance AnalystKey Responsibilities of Quality Assurance AnalystCollaborate with team members to conduct testing, QA, and validation of data movements, ensuring correct data presentation for both qualitative and numeric data.Engage with business and development teams to test changes and periodically review documents before the quarterly release of...
-
Senior Quality Assurance Engineer
4 weeks ago
Boston, United States Finance Full timeQuality Assurance AnalystKey Responsibilities of Quality Assurance AnalystCollaborate with team members to conduct testing, QA, and validation of data movements, ensuring correct data presentation for both qualitative and numeric data.Engage with business and development teams to test changes and periodically review documents before the quarterly release of...
-
Construction Quality Assurance Specialist
5 days ago
Boston, Massachusetts, United States Keville Enterprises Inc. Full timeJoin Our Team as a Construction Quality Assurance SpecialistKeville Enterprises, Inc. (KEI) is actively seeking qualified professionals to provide inspection services for a variety of public and private sector projects, including but not limited to airports, railways, highways, bridges, and water/wastewater systems. A positive demeanor is crucial for success...
-
Quality Assurance Specialist
3 weeks ago
Boston, United States firstPRO, Inc Full timefirstPRO is now accepting resumes for a Quality Assurance Tester role in Boston, MA. This is a 6+month contract and onsite 4 days per week.Essential Duties and Responsibilities:- Based on project requirements and technical design, develop & execute software test cases- Plan test schedules & strategies in accordance with project scope & delivery dates-...
-
IT Quality Assurance Manager
2 hours ago
Boston Heights, United States Arhaus Full timeThe IT Quality Assurance (QA) Manager will lead the offshore QA team, ensuring the effectiveness of quality assurance processes and methodologies. This role is crucial for enhancing testing strategies, developing and maintaining quality and reliability testing systems, and managing resource planning for the organization’s IT systems and products.This...
-
Senior Quality Assurance Engineer
4 days ago
Boston, Massachusetts, United States Stellar Elements Full timeJob OverviewAt Stellar Elements, we are dedicated to enhancing experiences and addressing challenges faced by our clients.Our focus lies in bridging the gap between business objectives and user expectations. We seek individuals who are passionate problem-solvers, equipped with insightful minds and a profound sense of empathy.Our clients appreciate our...
-
Senior Vice President of Quality Assurance
5 days ago
Boston, Massachusetts, United States Ironwood Pharmaceuticals Full timeCompany Overview:Ironwood Pharmaceuticals is a prominent player in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment landscape for GI disorders and setting new benchmarks in patient care. Our primary focus is on the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe,...
-
Senior Vice President of Quality Assurance
2 hours ago
Boston, Massachusetts, United States Ironwood Pharmaceuticals Full timeCompany Overview:Ironwood Pharmaceuticals is a prominent player in the gastrointestinal (GI) healthcare sector, dedicated to enhancing the treatment landscape for GI disorders and setting new benchmarks in patient care. Our focus lies in the discovery, development, and commercialization of groundbreaking therapies for patients suffering from severe, rare...
-
Senior Financial Analyst/Financial Analyst
6 days ago
Boston, United States Plymouth Rock Assurance Full timeSenior Financial Analyst / Financial Analyst The Financial Analyst will work closely with stakeholders within Plymouth Rock Assurance Corporation and across the various Enterprise Group teams to support strategic business planning and financial analysis. Primary responsibilities include generating term-end and mid-term reports of revenue and spend,...
-
Logistics and Quality Assurance Specialist
4 days ago
Boston, Massachusetts, United States European Watch Company Full timeJob OverviewWe are a prominent retailer with a growing fulfillment center, seeking a versatile individual capable of fulfilling various roles within our organization. The ideal candidate will possess strong multitasking abilities and exceptional organizational skills. Key ResponsibilitiesFulfillment Duties:Execute all general fulfillment tasks.Conduct...
-
Senior Financial Analyst/Financial Analyst
2 weeks ago
Boston, United States Plymouth Rock Assurance Full timeOverview: Senior Financial Analyst / Financial Analyst The Financial Analyst will work closely with stakeholders within Plymouth Rock Assurance Corporation and across the various Enterprise Group teams to support strategic business planning and financial analysis. Primary responsibilities include generating term-end and mid-term reports of revenue and...
-
Senior Quality Engineer
1 month ago
Boston, United States Servomex Full timeServomex, the world leader in gas analysis, is looking to expand our Quality Team. This is an exciting opportunity for a Senior Quality Engineer to join our high performing team at our site in Woburn. The successful candidate will work closely with our manufacturing teams at our US Technical Center to build quality through all of what we do. Reporting to...
-
Assurance Senior
3 months ago
Boston, United States Marcum Search Full timeMarcum LLP offers a great career with exceptional benefits. There’s a lot to think about when it comes to launching your career. At Marcum, we offer you a world of opportunity, a highly competitive salary, exceptional benefits, flexible work options, and industry-leading technology, all within an environment that values your contributions and supports your...