Quality Assurance Manager
Company: Elemental Enzymes
Location: Saint Louis
Posted on: March 20, 2023
Job Description:
About Elemental EnzymesElemental Enzymes was founded upon the
simple belief that we must do everything we can to improve
agricultural performance in a way that not only enables plants to
flourish but enriches and renews the planet with eco-friendly and
sustainable agricultural solutions. From products that enable
effective enzyme, peptide and protein inputs to foliar treatments
that hold the promise to renew entire industries, our focus to make
a positive difference in the world through people - like you and
me. Success is a byproduct of responsible production. That's why
Elemental Enzymes works to bring cross-disciplinary scientists and
processes together to create novel solutions to practical problems
with a shared goal of helping both the plant and the planet.*Job
Description*The Quality Assurance (QA) Manager will provide Quality
oversite to ensure compliance with applicable quality objectives
and regulatory requirements with the Quality department leading the
Quality Assurance function. The QA Manager will be responsible for
developing the QA function while leading day to day operations
within the QA function. This is a very exciting opportunity to join
a rapidly growing Biotechnology company and have influence on
creating strategic, tactical, and operational plans that align with
the company's strategic growth aspirations.The QA Manager will have
responsibilities in the following areas:*Product & Process:*
- Provide quality oversight and support for new product
introductions as primary quality point of contact
- Review executed production batch records, environmental
monitoring data (as required), analytical data, and associated
documentation, including any trends, deviations, and investigation
reports related to lot release of product disposition ensuring the
compliance of the whole product specifications
- Perform Product Disposition and Lot Closure using enterprise
resource planning (ERP) programs
- Track and respond to quality-related customer questions and/or
complaints.
- Reviews manufacturing, environmental monitoring, and quality
control data for in process and finished products
- Ensure process control measures are in place and followed in
product manufacturing.
- Identifies critical, non-critical, user calibrated, and
non-calibrated instruments per the process requirements (in
conjunction with process development) and manages the calibration
of the instrument to ensure compliance
- Works with operating entities to ensure that inspections,
statistical process control analyses and audits are conducted on a
continuing basis as specified to enforce requirements and meet
specifications
- Approve process and equipment qualifications and validations
and ensure proper handoff of product and process development
packages from process development team to manufacturing
- Manages and lead the product and process change management
ensuring product quality is not impacted with any product/process
proposed changes
- Provide QA oversight and review of deviations tied to lots.
Ensure deviations are properly initiated, investigated, and
resolved in accordance with established disposition timelines
- Provide QA oversight and approval of CAPAs. Ensures that
associated CAPAs are initiated and resolved
- Manage and monitor CAPAs for successful completion and
successful implementation
- Monitor all proposed changes of CAPAs through the Management of
Change (MOC) process
- As assigned, manage, and provide QA oversight for other
processes, including training
- Support Lean Manufacturing principles to ensure
process-in-controlQuality Systems:
- Leads the development and review of Standard Operating
Procedures (SOPs) to ensure quality objectives are met within the
organization
- Write, review, and approve Operating Procedures, Manufacturing
documents, Technical Transfer Protocols, and other controlled
documents under a Quality Managed System (QMS).
- Interact with key stakeholders such as R&D, Process
Development, Manufacturing
- Regulatory Affairs, and Commercial to ensure that Products are
manufactured in accordance with established procedures and
appropriate regulations
- Manage the tracking of deviations, CAPAs, and audits
- Manage all product and process change proposals and executed
changes through a Management of Change (MOC) process
- Maintains routine programs and processes to ensure high quality
products and compliance with current best practices, such as cGMP,
and with ISO9001 management requirements.
- Lead and participate in internal/external inspection and
audits
- Maintain metrics related to product disposition in support of
the Management Review.
- Generate and report data for managementLeadership & Management:
- The QA Manager will not have direct reports upon hire; however,
the QA Manager will responsible for identifying the QA function
needs, and built against the needs, including the personnel
necessary to have a world class Quality Assurance team
- Attracts, develops, and retains a high performing team to meet
the current and evolving needs of the business through effective
selection, training, and development, coaching and mentoring and
performance management
- Lead departments in development and successful completion of
individual and departmental goalsKnowledge, Experience, and Skills:
- Expert level knowledge of Quality Systems, specifically ISO
9001, is required
- Good working knowledge of Environmental and Occupational Health
and Safety systems, such as ISO 14001 and 45001, is required
- Good working knowledge of Good Manufacturing Practices
standards applicable to biotechnology is preferred
- Expert level knowledge on performing and leading audits
- Must be able to work as an individual contributor until the QA
function is built
- Ability to work on complex, non-routine assignments where
analysis of the situation or data requires a review of identifiable
factors
- Ability to effectively participate in cross-functional
teams
- Ability to coordinate the planning, organization, and
implementation of project deliverables within specified objectives
- An accountable team player who is detail and quality oriented
with solid understanding of quality assurance principles, systems,
and procedures
- Excellent attitude with strong verbal, written, and
interpersonal communication skills
- Self-starter, able to work independentlyBasic
Qualifications/Requirements:
- Bachelor's degree in the biological sciences,
biological/chemical engineering or related field and 10+ years of
progressive experience in a pharmaceutical, biotech, or biologics
operation, or equivalent education/work experience
- Expert knowledge of ISO 9001 Quality Management Systems is
required
- Working knowledge of ISO 14001/45001 EHS and OHS Systems is
required
- Good working knowledge of ERP Systems, i.e., SAP, is
required
- Prior experience in pharmaceutical and regulated biotech and or
chemical industry is required
- Good working knowledge of Good Manufacturing Practices, based
on FDA 21 CFR, is highly preferred
- Demonstrates knowledge of six sigma, LEAN, and root cause
analysis tools used for identifying and correcting deviations
- Demonstrates audit and investigation skills, and report writing
skills
- Ability to interpret and apply procedural and regulatory
guidance in potentially ambiguous
- Ability to understand risk and provide phase-appropriate
decisions
- Ability to effectively negotiate and build collaboration
amongst individuals
- Candidates must have good interpersonal skills, strong written
communication skills and strong analytical skills
- Comfortable in a fast-paced small company environment and
operate with minimal direction
- Ability to adjust workload based upon rapidly changing
priorities
- Role is onsite with potential flex schedule depending on the
candidate.Job LocationSt. Louis, MO, United StatesPosition
TypeFull-Time/Regular/ Exempt/ SalaryApplyPlease fill out the
application and attach a cover letter and CV/R--sum--. References
required upon request.Job Type: Full-time
Keywords: Elemental Enzymes, St. Louis , Quality Assurance Manager, Executive , Saint Louis, Missouri
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