- 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.
- 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
-
Operations Compliance Specialist
3 weeks ago
The RMR Group Newton, United StatesOverview: · The Operations Compliance Specialist ensures the accuracy and compliance of all Service Contracts/Service Orders, Construction Contracts, Certificates of Insurance as well as the Building Engines - CMMS (Work Order) System control. The Operations Compliance Specialist ...
-
Compliance Specialist I
2 weeks ago
LexisNexis Risk Solutions Cambridge, United States**Essential Job Functions**:This job description indicates the general level and nature of work expected of the incumbent. It is not a comprehensive list of specific duties or activities associated with the position. The incumbent may be asked to perform other duties as assigned. ...
-
Osha Compliance Specialist
5 days ago
CommTank, Inc. Wakefield, United StatesJob Overview: · We are seeking a skilled and detail-oriented Compliance Officer to join our team. As a Compliance Officer, you will be responsible for ensuring that our organization complies with all relevant regulations and standards. This role requires a strong understanding of ...
-
Compliance and Credentialing Specialist
5 days ago
Boston Public Health Commission Boston, United StatesThe mission of the Boston Public Health Commission (BPHC) is to work in partnership with communities to protect and promote the health and well-being of all Boston residents, especially those impacted by racism and systemic inequities. The BPHC envisions a thriving Boston where a ...
-
Retail Compliance Specialist
3 days ago
C3 Industries Boston, United StatesJOB SUMMARY: · The Retail Compliance Specialist is responsible for ensuring that assigned retail stores are operating in compliance with state and local ordinances, rules and regulations. · JOB DUTIES: · Core duties and responsibilities include the following. Other duties may be ...
-
Senior QA Compliance Specialist
1 week ago
Anika Therapeutics Bedford, United StatesPosition 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 Dev ...
-
QA Compliance Specialist I
1 week ago
Anika Therapeutics Bedford, United StatesSummary 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 standard ...
-
Senior QA Compliance Specialist
2 weeks ago
Anika Bedford, United StatesPosition 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 Dev ...
-
Senior QA Compliance Specialist
4 weeks ago
Anika Therapeutics Bedford, United StatesPosition 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 De ...
-
RZ Compliance and Process Specialist
3 weeks ago
Nebula Ventures Mendon, United StatesAre you known for your collaborative work style, enjoy a wide variety of tasks, and take responsibility with enthusiasm? · Then FI-TS is the right place for you. · As one of the largest IT outsourcing partners in the financial and insurance industry, FI-TS serves leading banks, i ...
-
Senior Compliance Specialist
2 weeks ago
Kaztronix LLC Billerica, United StatesSr. Associate Compliance (Product Quality) Fulltime Onsite · We can Relocate · Job Duties: · The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures complia ...
-
Senior Compliance Specialist
3 weeks ago
Kaztronix Billerica, United StatesSr. Associate Compliance (Product Quality) Fulltime Onsite · We can Relocate · Job Duties: · The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures complian ...
-
Senior Compliance Specialist
2 weeks ago
Kaztronix Billerica, United StatesSr. Associate Compliance (Product Quality) Fulltime Onsite · We can Relocate · Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match. · Job Duties: · The Sr. Associate Compliance provides scientific support in the root ...
-
Senior Compliance Specialist
1 week ago
Kaztronix Billerica, United StatesSr. Associate Compliance (Product Quality) Fulltime Onsite · We can Relocate · Job Duties: · The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures comp ...
-
Sr. Trade Compliance Specialist
3 weeks ago
Desktop Metal Burlington, United StatesDesktop Metal (NYSE: DM) is pioneering a new generation of additive manufacturing technologies focused on the production of end-use parts. We offer a portfolio of integrated additive manufacturing solutions for engineers, designers and manufacturers comprised of hardware, softwar ...
-
Compliance Specialist
1 week ago
Alphanumeric Systems Cambridge, United StatesAlphanumeric is hiring a COMPLIANCE SPECIALIST to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · We have an exciting new opportunity for an experienced Compliance Specialist who will work closely w ...
-
Compliance Specialist
1 week ago
Randstad North America, Inc. Cambridge, United StatesExciting new opportunity for an experienced Compliance Specialist who will work closely within the Manufacturing Compliance group to achieve department goals. The Compliance Specialist is also responsible for owning and driving manufacturing complian Compliance Specialist, Compli ...
-
Compliance Specialist
3 weeks ago
eTeam Cambridge, United StatesTitle: Compliance Specialist - Level 2 · Location:- Cambridge, MA · Duration - 12 months, but we are looking to make it full-time if the contractor performs well** · Hybrid Remote · Pay Rate Range:- $61.42 on w2 · ***Candidate MUST have a MFG background*** · Shift = 1st shi ...
-
Compliance Specialist
1 week ago
Randstad North America, Inc. Cambridge, United StatesAs a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report Compliance Specialist, Compli ...
-
Compliance Specialist
5 days ago
Alphanumeric Systems Cambridge, United StatesAlphanumeric is hiring a Quality Systems Specialist to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · POSITION TITLE: Quality Systems Specialist · ON SITE - 9am-5pm / Monday - Friday · PAY - $52.35 ...
Senior QA Compliance Specialist - Bedford, United States - Anika Therapeutics
Description
Position 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 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:
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:
