Senior QA Compliance Specialist
4 weeks ago
The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier audits as assigned, participates in customer and regulatory audits as part of the Audit Team, Maintain the Design History Files (DHF), Design Master Records (DMR), track implementation of internal and external and supplier audits observations for on time closure and is the SME trainer of junior QA personnel. All activities are performed according to internal Quality System requirements, cGMP, current ISO 13485 standards as well as other regulatory requirements such as EU, FDA, TGA, and ANVISA.
Strategic Focus Areas:
- Design, implement and participate in projects and activities which support the top and bottom line growth of the company through compliant improvement activities.
- Provide leadership for quality compliance activities and initiatives.
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate government and regulatory authorities.
- Review batch records and certificates of analysis for accuracy and completion prior to final product release.
- Responsible for nonconformance and planned deviations investigations review and approval including root cause analysis, tracking and trending for on time closure. Maintain associated tracking logs.
- Responsible for out of specification and environmental excursion investigations review, approval, tracking and trending for on time closure.
- Manage the CAPA and Change Control programs as assigned and maintain associated tracking logs.
- Maintain the Approved Supplier List including updating and reviewing performance of vendors.
- Responsible for the maintenance the Design History Files (DHF) and Design Master Records (DMR).
- Perform QA review of new and revised procedures, technical protocols, validations and reports as assigned.
- Perform internal and external audits as assigned including internal Quarterly Walkthroughs.
- Manage the facility monthly walkthroughs program performed by other departments, ensuring follow up for correction action implementation, on time closure and trending.
- Responsible for Material Master data transactions in the ERP system, specifically SAP.
- Provide floor support to production departments to include line clearance and in-process checks as needed.
- Assist in the maintenance of the Quality System.
- Participate in project teams and perform other related duties as assigned.
- Provide document control support.
- Issue and reconcile batch records
- Responsible for other duties and projects as assigned.
Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires current knowledge of all applicable national and international regulations and regulatory guidance.
Supervisory Responsibilities:
None
Required Qualifications:
- Bachelor’s Degree preferably in the life sciences or equivalent experience
- 5+ years industry experience in a QA function.
- Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
- Knowledge of the FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil) regulatory requirements.
- Experience auditing in a GMP/ISO environment.
- Ability to interact positively and professionally with internal and external customers.
- Ability to work autonomously, effectively manage time and deliver results on time.
- Ability to perform Materials Master Data transactions in SAP
- Requires proficiency in word processing, spreadsheets, and databases
- Excellent presentation skills, both written and in platform presentation format
-
Senior QA Compliance Specialist
3 weeks ago
Bedford, United States Anika Therapeutics Full timePosition Scope: The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...
-
Senior QA Compliance Specialist
3 weeks ago
Bedford, United States Anika Full timePosition Scope:The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...
-
Senior QA Compliance Specialist
3 weeks ago
Bedford, United States Anika Full timePosition Scope:The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...
-
Senior QA Compliance Specialist
3 weeks ago
Bedford, United States Anika Full timePosition Scope:The Senior Quality Assurance Compliance Specialist performs compliance activities in support of production departments. Areas of responsibilities may include review of documents such as batch records, charts and logs. The Senior Compliance Specialist manages Deviations, CAPA, Change Controls, Supplier Program, performs Internal and Supplier...
-
QA Compliance Specialist I
4 days ago
Bedford, United States Anika Therapeutics Full timeSummary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as...
-
Senior Associate, QA
5 days ago
Bedford, United States Tandym Group Full timeOur client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only**As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility...
-
Senior Associate, QA
4 days ago
Bedford, United States Tandym Group Full timeOur client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only**As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility...
-
Senior Associate, QA
5 days ago
Bedford, United States Tandym Group Full timeOur client, a leader in the pharmaceutical industry, is seeking a QA Senior Associate to join their team. **This job is 5 days onsite in Bedford, MA** **W2 Only** As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing...
-
Senior QA Associate
5 days ago
Bedford, United States Planet Pharma Full timeAs a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...
-
Senior QA Associate
5 days ago
Bedford, United States Planet Pharma Full timeAs a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...
-
Senior QA Associate
5 days ago
Bedford, United States Planet Pharma Full timeAs a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...
-
Senior QA Associate
4 days ago
Bedford, United States Planet Pharma Full timeAs a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...
-
Senior QA Associate
7 hours ago
Bedford, United States Planet Pharma Full timeAs a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. The site is a multi-product facility which will be used for drug substance manufacturing, drug product manufacturing, and packaging /...
-
QA Compliance Specialist
3 days ago
Bedford, United States Actalent Full time**Description**: - Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will provide floor support to production departments to include line clearances, in-process checks and assistance...
-
Sr. QA Compliance Analyst
4 days ago
Bedford, United States Actalent Full timeGreat opportunity to get your foot in the door with one of the top Biotech companies in the Bedford, MA area! If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com Description: * Perform batch record review * Run deviations and investigations * Manage the CAPA and Change Control programs * Perform QA review...
-
New Bedford, United States Senior Living Recruiting Specialist Full timeNow seeking Certified CNA or HHA. Must be certified. Your Perfect Client Match & Great Benefits Are you an experienced CNA that is looking for stability, an opportunity for career growth and great benefits? If you answered yes, this job may be for you. Our client is seeking CNAs that have a deep passion for the residents they serve, and a company...
-
New Bedford, United States Senior Living Recruiting Specialist Full timeNow seeking Certified CNA or HHA. Must be certified. Your Perfect Client Match & Great Benefits Are you an experienced CNA that is looking for stability, an opportunity for career growth and great benefits? If you answered yes, this job may be for you. Our client is seeking CNAs that have a deep passion for the residents they serve, and a company...
-
Senior Regulatory Affairs Specialist
4 days ago
Bedford, United States Werfenlife SA. Full timeBedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States Country United States Shift About the Position Overview Werfen Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and...
-
Bedford, United States GZA GeoEnvironmental Full timeGZA GeoEnvironmental, Inc. (GZA) is currently seeking a Senior Level EHS Regulatory Compliance Specialist/Project Manager to join ourBedford, NHteam. The ideal candidate must be a highly motivated independent self-starter with a client-oriented focus. The position will include performing various technical tasks at client facilities, conducting complex...
-
Bedford, United States GZA GeoEnvironmental Full timeGZA GeoEnvironmental, Inc. (GZA) is currently seeking a Senior Level EHS Regulatory Compliance Specialist/Project Manager to join ourBedford, NHteam. The ideal candidate must be a highly motivated independent self-starter with a client-oriented focus.The position will include performing various technical tasks at client facilities, conducting complex...
