Summary of Primary Responsibilities:
The Quality Assurance (QA) Compliance Specialist performs compliance activities in support of production and engineering; ensuring all activities are performed according to internal Quality System requirements, ISO 9000 standards and the expectations of customers that operate in a cGMP environment. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and inspection/approval of incoming materials for release. The QA Compliance Specialist can perform audits, and can support customer and regulatory audits as part of the Audit Team. Some microbiological knowledge/experience with aseptic technique is preferred as candidate may periodically provide additional support to quality control testing laboratory.
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Strategic Focus Area:
Effectively collaborates with internal colleagues to meet corporate objectives and drive business results.
Specific Responsibilities:
Review and approve QC Lab testing and supportive documents in final release of product Operations.
Review batch records for Systems and Consumables for accuracy and completion prior to final release of product.
Perform Calibration activities.
Support Supplier Management activities.
Performs SAP Transactions.
Review and approve incoming materials for release.
Provide quality assurance support of investigations including: nonconformance and root cause analysis.
Complete audit activities as assigned.
Assist in the maintenance of the Quality System.
Perform support testing for quality control lab as needed (printing/processing EM reports from equipment, growth promotion testing (GPT), leak testing, and pH testing).
Performs Document Control Support to include Agile document administration and Standards Management activities.
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.
Supervisor Responsibilities:
None
Required Qualifications:
Bachelor’s Degree or relevant experience in the life sciences.
1-2 years minimum experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role.
Knowledge of cGMP requirements is preferred.
Requires computer competence.
Excellent written and verbal communication skills.
Desired Experience, Knowledge, and Skills:
Experience working in a GMP/ISO environment.
Knowledge of some microbiological testing and function tests (i.e. GPT, EM, leak testing, etc.).
Good presentation and organization skills.
Attention to detail.
Capable of executing tasks per defined policies and procedures to resolve routine issues.