5909 - GMP Quality Auditor / Senior Quality Specialist en Verista, Inc.
Verista, Inc. · Boston, Estados Unidos De América · Onsite
- Professional
- Oficina en Boston
Description
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
The Senior Quality Specialist will demonstrate strong collaboration with key cross functional colleagues from Pharmaceutical Sciences, CMC Regulatory, GDP Finish Goods, Supply Chain and R&D Quality to compliantly advance programs through the product lifecycle. The ideal candidate will possess a working knowledge of early phase to commercial GMP drug substance and drug product manufacturing regulations and good written and verbal communication skills.
GMP Quality Auditor / Senior Quality Specialist Responsibilities:
- Support quality oversight for root-cause analysis and product impact assessments
- Ensure appropriate CAPA actions are identified for deviations, OOS, and OOT investigations
- Support change control assessments, implementation, and closure
- Identify and facilitate continuous improvement efforts
- Support drafting and revising Quality Agreements between CMOs/Suppliers and client
- Support cross-functional working teams, applying strong communication and collaboration skills
- Perform review of executed batch documentation from external and/or internal manufacturing and testing (executed batch records, release data, in-process controls, testing and stability data)
- Use knowledge of functional area to inform decisions and support the success of batch disposition for drug substance, drug product intermediate, drug product and finished goods
- Support GMP document review, including certificate of analysis, specifications
Requirements:
- Bachelor's Degree in industry-related field
- 3+ years of Operational QA experience in analytical or manufacturing setting
- Experience in small molecule manufacturing - additional experience with biologics, devices, gene therapy a plus
- Experience supporting cross-functional projects/teams within stated objectives and timelines
- Good communication skills (written and verbal) and the ability to exchange potentially complex information
- Able to integrate activities with other groups, departments and project teams as needed
- Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
- Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives
- Expanded conceptual knowledge of cGMP's in a pharmaceutical setting
- Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA
- Practical GxP knowledge and understanding across lifecycle of the product
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
Benefits
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
