- Utilize SOPs in order to audit various aspects of regulated projects and approving Certificates of Analysis, Stability Reports and Validation Reports.
- Audit relevant experiment documentation from testing performed for regulated projects and communicate observations to Technical Leads.
- Review of test method validation/transfer protocols, and validation/transfer reports, to ensure the work meets with ICH and FDA expectations.
- Assist in drafting of SOPs related to the site Quality System.
- Review of documents (SOPs, Test Methods, Project Reports, Validation Protocols and Reports) for compliance with SOPs and cGMP regulations.
- Publish new and revised SOPs, Test Methods, and Protocols.
- Review and approval of OOS and Atypical investigations, including any relevant project deviations.
- Provide compliance support for equipment qualification program through preparation and reviewing of calibration and validation protocols, and Change Control documentation.
- Serve as Lead or Supporting Auditor for internal audits, and provides support to customer audits
- Works with staff to ensure that all project deviations and investigations have the correct root cause and corrective/preventive actions have been assigned
- Provides input to internal project meetings to ensure project issues are identifed, resolved and escalated as needed
- Acts as QA SME for aspects of site's QMS or Quality responsibility area, including ownership of process and related SOPs
- Manages project as QA representative and manages all aspects, including approvals of test methods, protocols, reports, investigations, and related communication with project management and tech leads
- Communicate cross-functionally with peers, management, and external customers in oral, presentation, and written forms
- Provide training to staff on topics for which the Sr. Specialist is an SME
- Suggests and drives continuous improvement projects within the QA team
- Other duties as assigned.
- Provide consultation to company personnel on QA-related matters, which may require in-depth evaluation of various factors.
- Meeting personal and company deadlines and deliverable due dates
- Adheres to SOPs and GMP/GLP/Safety requirements.
- Maintains a safe and clean working environment.
- The Specialist, Quality Assurance, must have a four-year degree in Chemistry or Pharmaceutical Sciences, or related experience, and 6-8 years of experience in a pharmaceutical environment in a Quality-related field.
- Thorough understanding of US GMPs and 21 CFR Part 211
- Good working knowledge of computers and programs such as MS Word and Excel.
- Ability to build relations and interact effectively
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Senior Quality Assurance Specialist - Morrisville, United States - Recipharm Laboratories
Description
Recipharm Laboratories officially became Bespak as of 4/1/2024.
Recruiters please do not contact this job poster. Please be advised: Bespak Laboratories does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.
Bespak is a pharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers development and manufacturing solutions for a variety of medications, including medical devices such as pressurized metered dose inhalers (pMDI), soft mist inhalers (SMI), dry powder inhalers (DPI), nasal sprays and medical check valves.
Our research and development facility in Research Triangle Park, NC, USA is seeking a Senior Quality Assurance Specialist to join our Quality Assurance Department. This position is onsite only.
The Sr. Specialist, Quality Assurance, is responsible for auditing project notebooks and related laboratory data, reviewing and issuing SOPs and other Quality System-related documents, and for maintaining GMP compliance through auditing of project related documentation. The Sr. Specialist will be an SME in key areas of Quality such as test method validation and will be proactive in resolving issues that are encountered.
The Senior Specialist may also be responsible for managing the QA Specialists, and for ensuring that other QA tasks as outlined below are assigned and managed within the QA team.
Responsibilities
The employee must possess the ability to stand and/or walk for up to 8 hours a day and carry up to 25 pounds. This position involves repetitive motion of the arm, wrist, hand and fingers with the ability to feel and handle work materials for up to 8 hours per day. The position also requires the ability to carry out tasks involving extensive reaching, crouching and bending. Day to day tasks may involve handling of and the ability to identify hazardous chemicals and materials.
We offer a competitive compensation and benefits package including:
Full Benefits (Medical, Dental, Vision, Life, Disability)
401(K) with Company Match
Paid Vacation, Sick Time and Parental Leave
Dependent Care FSA
Educational reimbursement program
**Relocation assistance is not provided for this position. Candidate must be able to commute daily to the job site**
COVID-19 considerations:
Vaccinations strongly recommended for all adults.
