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Bedford, MA | Full Time
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QA Compliance Specialist I
Anika Bedford, MA
$65k-82k (estimate)
Full Time | Retail 1 Week Ago
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Anika is Hiring a QA Compliance Specialist I Near Bedford, MA

Summary 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 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 with investigations. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team.
Strategic Focus Area:Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge.
Specific Responsibilities:
  • Review and approve supplemental logs, charts and other documents in support of cGMP Operations.
  • Review batch records for accuracy and completion prior to final release of product.
  • Perform product releases specifically fills and intermediates lots.
  • Coordinate product releases with distributors and customers as needed.
  • Review and approve incoming materials for release.
  • Provide quality assurance support of investigations including: nonconformance and root cause analysis.
  • Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned.
  • Issue, review and reconcile batch records as needed.
  • Assist in the maintenance of the Quality System.
  • Participate in project teams and perform other related duties as assigned.
Job Complexity:Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance.
Supervisor Responsibilities:none
Required Qualifications:
  • Bachelor’s Degree or equivalent experience
  • Medical device quality system management experience or an acceptable combination of education and experience will be considered. Internship experience may be considered.
  • Knowledge of GMP, FDA, ISO requirements.
  • Requires computer competence, including experience with database and Microsoft Office.
  • Excellent written and verbal communication skills.
Desired Experience, Knowledge, and Skills:
  • Experience working in a GMP/ISO environment.
  • Good presentation and organization skills.
  • Attention to details.
  • Capable of executing tasks per defined policies and procedures to resolve routine issues.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Retail

SALARY

$65k-82k (estimate)

POST DATE

06/19/2024

EXPIRATION DATE

07/14/2024

HEADQUARTERS

ATLANTA, GA

SIZE

<25

FOUNDED

2013

CEO

FAHMIDA NORRALI

REVENUE

<$5M

INDUSTRY

Retail

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Anika
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Anika
Full Time
$42k-54k (estimate)
1 Week Ago
Anika
Full Time
$42k-55k (estimate)
1 Week Ago

The job skills required for QA Compliance Specialist I include Internal Audit, Verbal Communication, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Compliance Specialist I. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Compliance Specialist I. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for QA Compliance Specialist I positions, which can be used as a reference in future career path planning. As a QA Compliance Specialist I, it can be promoted into senior positions as a Compliance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Compliance Specialist I. You can explore the career advancement for a QA Compliance Specialist I below and select your interested title to get hiring information.