- 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
- 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.
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Senior Quality Assurance Specialist - Boston, United States - DPS Group Global
Description
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
Skills and Qualifications
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.
