Careers – Quality Assurance Manager – Albuquerque, NM, USA
The selected candidate will lead development of the company’s QMS in keeping with evolving needs, for compliance to GXP/CLIA/FDA/ISO requirements and for continued improvement in compliance and operational efficiency.
- Chair management review process, documentation and follow-up
- Internal audit function
- QMS training for staff
- Review, investigate and respond to all complaints
- Promote quality achievement and performance improvement throughout the organization and with key vendors.
- Sets QA compliance objectives in alignment with business objectives and ensure that targets are achieved.
- Provide oversight of compliance of third parties to QMS agreements.
- Manage QMS document access, new document creation, revisions and necessary training. Ensure documentation is in compliance with global regulatory filings and applicable global regulatory requirements.
- Establish and manage budgets for the unit.
- Define and implement quality system procedures and policies.
- Develop proposals for system and process development or modification to support the company’s mission of continuous improvement.
- Develop/review SOPs/documents to fulfill global development requirements.
- Assist in the establishment of product and material specifications and ensure that product complies with specifications and meets all necessary standards for safety, purity, identity and efficacy.
- Review or oversees the review and approval of deviations and change control to all documents and investigates the results of product and/or process non-conformance.
- Establish a vendor audit plan and ensure timely audits and effective closure of quality issues of supplier and contract organizations providing critical raw materials or performing GXP services.
- Maintenance of CAPA system. Lead or oversee any investigations and ensure the execution and closure of CAPA plans.
- Participate in the review of quality sections of contractor agreements and leads the preparation and approval of QA Agreements and ensure operations and activities are in compliance with such approved agreements and QMS.
- Provide detailed project timeline and budget projections related to QA operations in support of the company’s development programs.
- Maintain document control system
- Support the internal transition of paper to electronic files and transfer of legacy documents associated with product license/acquisitions.
- Effectively manage the company’s document and material management system including oversight of off-site storage of active and archived materials.
- Regularly meets with the VP Product Development, Quality & Regulatory affairs, VP Facilities and Manufacturing, to report quality issues and resolutions, review recent results, set next plans, and assure appropriate progress is being made on assigned programs.
- Maintains a clean and safe work environment and follows all safety policies and procedures.
- Other assignments as directed by Supervisor.
- Provide leadership, establishing, and maintaining quality management systems and processes that meet the quality requirements of the company.
- This position has supervisory responsibilities over one or more supervisors and their employee’s in the Quality Assurance department.
Qualifications and Required Skills
- Bachelor’s degree (B. A.) from four-year College or university; or four to ten years related experience and/or training in Quality Assurance preferred; or equivalent combination of education and experience.
- Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- To perform this job successfully, an individual must have knowledge of database, spreadsheet and word processing software.
- 7-10 years of related experience in pharmaceutical or medical device industry (preferably pharmaceutical).
- Quality Assurance, ISO, Six Sigma, or other Quality Training or Certification.
This position is based at our headquarters in Albuquerque, NM. Remote candidates will not be considered.
Full-time employees are offered very competitive salaries and profit sharing plan, 100% company sponsored medical and dental insurance.
Working at Indica Labs
Indica Labs is a profitable, privately held, local NM company that provides software solutions for fast, quantitative evaluation and management of pathology images using HALO®, HALO AI™ and HALO Link™. Pharmaceutical, healthcare, and research organizations worldwide have adopted HALO for high-throughput, whole-slide image quantification in areas such as neuroscience, ophthalmology, metabolism, oncology, respiratory, and toxicological pathology.
All of our employees are valued tremendously and never taken for granted. Since inception in 2011, the company has maintained a high employee retention rate which can be attributed among other things to:
- Generous compensation and profit-sharing plans
- 100% company paid health & dental insurance
- 401K with company match
- Flexible work schedules
- A work environment that’s positive, challenging, rewarding, and fun
To be considered for this position, please submit your CV/Resume and Cover Letter to: email@example.com