QA/QC Manager
at Aurorium LLC
Delaware Water Gap, PA 18327, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 22 Nov, 2024 | Not Specified | 29 Aug, 2024 | N/A | Excel,Access,Sap,Thinking Skills,Time Management,Ftir,Communication Skills,Powerpoint,Skills Analysis | No | No |
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Description:
COMPANY OVERVIEW
Aurorium is the materials innovation partner that helps global manufacturers harness the power of possibility to make the world a better place. Their specialty ingredients and high-performance materials enhance quality of life, support health and wellness, and enable customers to deliver value-added solutions. Key industries served include household products, coatings & adhesives, energy & electronics, healthcare, food & beverages, agriculture, transportation, and paper & packaging. A Responsible Care® company, Aurorium follows the highest regulatory standards across all manufacturing facilities. The company’s global integrated supply chain offers the customer product consistency, easy access, supply security and reasonable turnaround on delivery. Aurorium is committed to operating at the highest levels of manufacturing consistency, quality control and safety.
JOB SUMMARY:
The Quality Manager is charged with overseeing all Quality Assurance and Quality Control activities. This includes Quality Assurance activities of developing and maintaining a system to assure that all products are manufactured according to applicable site policies/procedures, and product specifications. It also includes maintaining responsibility for the Quality Control laboratory and equipment therein. Will manage internal and external quality related investigations, internal audits, compliance audits, and customer audits. Will also drive continuous improvement initiatives across the organization. Provides ongoing support to ensure ISO 9001 compliance for joint ISO certificate.
EDUCATION AND QUALIFICATIONS:
- BA/BS in Sciences with 3-5 years quality systems management experience (chemical manufacturer preferred);
- Computer literate: MS Word, Excel, Access, PowerPoint; SAP, Process Map experience preferred
EXPERIENCE
- Experience in a manufacturing environment preferred.
- Ability to solve practical problems and deal with a variety of changing situations.
- Technical/Professional Knowledge and Skills analysis
- Strong time management and prioritization skills
- Preferred experience with HPLC, UV/Vis, GC, and FTIR
KNOWLEDGE, SKILLS, AND ABILITIES:
- Self-motivated and ability to work within a fast-paced environment
- Excellent written and verbal communication skills
- Demonstrated strong computer, analytical and critical thinking skills
- Embodies the core values of Aurorium:
- credible: keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions
- outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact
- driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness
- empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standard
Responsibilities:
ROLE SPECIFIC RESPONSIBILITIES:
- Write/revise quality management SOP’s and work instructions
- Write/revise quality control SOP’s and work instructions
- Manage the Quality Control Lab. Complete PDR’s, training, work schedules and performance management.
- Manage and facilitate all compliance activities for ISO, cGMP, etc. Provide training for same.
- Ensure efficient and safe operations of the lab. Manage lab equipment calibration and maintenance programs.
- Maintain site specifications (product, raw material, packaging, and customer specific)
- Lead Quality related investigations, write reports, and recommend corrective action.
- Manage internal audit program, customer audits, and compliance audits, including follow up activities for any nonconformances.
- Maintain SAP quality management module, including COA generation
- Ensure I/O/P Qualification and Validation protocols for new and existing equipment and analytical methods are performed.
- Participate in corporate quality initiatives and implement at local level, as applicable
TECHNICAL & DESCRIPTION OF DUTIES:
- General ability to sit, stand and move around the facility. Lifting up to 25 pounds.
- Assign work duties and oversee laboratory employees; train as necessary
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Software Testing, Clinical Pharmacy
Graduate
Proficient
1
Delaware Water Gap, PA 18327, USA