Quality Assurance Specialist

at  Polysciences Inc

POLYSCIENCES –

In Polysciences 60 years of operation, we’ve grown into a nexus of technical operations and scientific laboratories housing custom synthesis, contract manufacturing and packaging and laboratory products. Through these three divisions, we are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.
At Polysciences, we take chemistry beyond the ordinary. We produce and sell specialty chemicals for several industries including pharmaceuticals, electronics, academic research and personal care. We need driven, detail-oriented team players to support our growing operations and customer base, and identify further opportunities for growth.
We’re looking for a Quality Assurance Specialist to safely execute directives of the Quality Assurance Department that incorporate our core competencies to achieve the stated responsibilities in support of the company objectives.

QUALIFICATIONS:

• Education: Bachelors degree preferably in a science or related discipline.
• Experience: Minimum 5 years experience in a Quality Assurance role or a GMP environment
• Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel).
• Lead Auditor training to ISO 13485 preferred
• Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
• Excellent judgment, decision-making, training/mentoring skills and verbal/written communication skills.
• Strong leadership, organizational skills and detail oriented.
• Able to prioritize workload and manage multiple tasks.
  We’ve got great employees who work hard but like to have a bit of fun. We dont have the bureaucracy, acronyms, corporate speak, etc. like mega corporations, and we like it that way. We are serious about business and enthusiastic about our work environment!

Oversee daily operational activities and ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Manage the direct activities of an area within a department or function.
• Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures.
• Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Participate in the preparation and review of QA files in preparation for site visits and regulatory inspections; assure that QA audit files are retained.
• Participate in client site visits and regulatory inspections.
• Management of a Customer Complaint system that can lead teams to customer-oriented and compliant solutions.
• Management of Nonconformance, CAPA, OOS systems.
• Perform internal audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
• Assure the suitability of materials and supplies for compliance with specifications.
• Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product.
• Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews

Oversee daily operational activities and ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Manage the direct activities of an area within a department or function.
• Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures.
• Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
• Participate in the preparation and review of QA files in preparation for site visits and regulatory inspections; assure that QA audit files are retained.
• Participate in client site visits and regulatory inspections.
• Management of a Customer Complaint system that can lead teams to customer-oriented and compliant solutions.
• Management of Nonconformance, CAPA, OOS systems.
• Perform internal audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
• Assure the suitability of materials and supplies for compliance with specifications.
• Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product.
• Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.