Director Of Quality Operations
Current
Jan 2023 - Present
AeroLeads people directory · profile
Anne Bolin Email & Phone Number
Director of Quality Operations
at
ProCell Surgical Inc.
1 work email found
@procellsi.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Director of Quality Operations
Location
Greater Boston, United States
Who is Anne Bolin? Overview
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Quick answer
Anne Bolin is listed as Director of Quality Operations at ProCell Surgical Inc., based in Greater Boston, United States. AeroLeads shows a work email signal at procellsi.com and a matched LinkedIn profile for Anne Bolin.
Anne Bolin previously worked as Senior Quality Assurance Specialist at Procell Surgical Inc. and Senior Quality Specialist, Systems and Compliance at Lakepharma, Inc.. Anne Bolin holds Bachelor Of Science (B.S.), Molecular Biology from Bridgewater State University.
Company email context
Email format at ProCell Surgical Inc.
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{first_initial}{last}@procellsi.com
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Profile bio
About Anne Bolin
Quality Assurance professional with a strong background in regulatory affairs, considerable experience in quality system compliance against MDSAP, ISO, EU MDR and FDA requirements for medical devices as well as with internal/external auditing, laboratory pharmaceutical formulation and material management systems.
Listed skills include Quality Assurance, Laboratory, Team Building, Fda, and 17 others.
Current workplace
Anne Bolin's current company
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10 roles
Anne Bolin work experience
A career timeline built from the work history available for this profile.
Senior Quality Assurance Specialist
Responsible for overseeing and managing various QMS sub-systems (e.g. Internal Audits, CAPAs, Risk Analysis), overall GMP compliance, and driving critical process improvements. Ensuring QMS is compliance to MDSAP requirements.
May 2021 - Jan 2023
Senior Quality Specialist, Systems And Compliance
Lakepharma, Inc.
Responsible for the support and compliance of a quality system for cGMP processes to align with the requirements of FDA 21 CFR parts 210 and 211. Assist in establishing a robust quality system with involvement in documentation, training, deviations, CAPA, nonconformances, change management, etc. Additional responsibilities include review and approval of raw and manufactured material based on internal and client specifications, review of risk management for completeness, feasibility and adequacy, support supplier management and the internal/external audit programs.
Jul 2018 - Jul 2019
Quality Assurance Lead
Key role in the implementation and maintenance of the Quality System and all documentation related to the QS. Responsible for the management of DCRs, ECRs, and NCRs as well as reporting metrics on these areas during site management review. Additional responsibilities include daily review activities of finished good products and certificate of analysis for final release, validation of equipment, and participate in complaint review.
Oct 2015 - Jul 2018
Qa Compliance Specialist
Responsibilities include overseeing the complaint processes including investigation, FDA and EU Vigilance reporting, and closure as well as review and process returns and disposition through the NCMR process and management within the Material Review Board. Participate in internal and third party audits.
Jul 2015 - Oct 2015
Quality Assurance Specialist
Responsible for providing support from a regulated systems perspective for a GMP/ISO manufacturing environment. Activities include batch record review, inspection, and release of finished product and intermediate solutions based on internal or customer specifications; Participate in the Material Review Board for Non-conforming Material Reports (NCMRs); Accountable for incoming complaints and the direction of internal investigations; As well as review, maintain, and generate metrics for process deviations. out of specifications, and product reworks.
May 2012 - Jul 2015
Technical Care Specialist
Axis-Shield Poc
Responsible for support, training and technical issue resolution for point-of-care clients, as well as account management to support sales, client contract compliance, and instrument testing/quality control.
Nov 2010 - May 2012
Pharmacy Scheduler/Laboratory Technician
Management of schedule for Charles River pharmacy, a critical role in ensuring timely formulations to meet clients’ preclinical study needs and the work of numerous other lab departments.Responsibilities: Provide weekly schedule for pharmacy formulations, daily formulation dispensations, room allocations, and shipments. Report departmental metrics; coordinate pharmacy activities with other departments; provide weekly statistics based on workload and staffing.
May 2009 - Aug 2010
Laboratory Technician I
Formulate Test Material and other study related items on a daily basis; perform data review of preparations; understand and review study protocols.
May 2008 - May 2009
Assistant Manager
Too, Inc.
Jun 2000 - May 2008
2 education records
Anne Bolin education
Bachelor Of Science (B.S.), Molecular Biology
Bridgewater State University
Bachelor Of Science, Biology
Bridgewater State University
FAQ
Frequently asked questions about Anne Bolin
Quick answers generated from the profile data available on this page.
What company does Anne Bolin work for?
Anne Bolin works for ProCell Surgical Inc..
What is Anne Bolin's role at ProCell Surgical Inc.?
Anne Bolin is listed as Director of Quality Operations at ProCell Surgical Inc..
What is Anne Bolin's email address?
AeroLeads has found 1 work email signal at @procellsi.com for Anne Bolin at ProCell Surgical Inc..
Where is Anne Bolin based?
Anne Bolin is based in Greater Boston, United States while working with ProCell Surgical Inc..
What companies has Anne Bolin worked for?
Anne Bolin has worked for Procell Surgical Inc., Lakepharma, Inc., Biolegend, Ace Surgical, and Seracare Life Sciences.
How can I contact Anne Bolin?
You can use AeroLeads to view verified contact signals for Anne Bolin at ProCell Surgical Inc., including work email, phone, and LinkedIn data when available.
What schools did Anne Bolin attend?
Anne Bolin holds Bachelor Of Science (B.S.), Molecular Biology from Bridgewater State University.
What skills is Anne Bolin known for?
Anne Bolin is listed with skills including Quality Assurance, Laboratory, Team Building, Fda, Sop, Lifesciences, Biotechnology, and Glp.
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