Quality Assurance Manager - Morrisville, United States - Recipharm Laboratories Inc.

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 Manager of Quality Assurance to lead our Quality Assurance Department. This position is onsite only.

The Manager / Sr. Manager, Quality Assurance, at Bespak Laboratories is primarily responsible for managing the project review activity within the Quality Assurance team, ensuring that all project work is assigned and completed per Recipharm SOPs and applicable regulations, and is completed per agreed delivery due dates. The Manager will ensure that all site projects have an assigned QA rep who will be responsible for all aspects of the project, including document and report review, and investigations and deviations.

The Manager will 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. Finally, the Manager is responsible to input into improvements and direction of the QA function at Bespak Laboratories.

Responsibilities

• Perform managerial duties as required, e.g. 1:1s with direct reports, personnel development plans and performance appraisals, ensure that company policies are adhered to, plan department meetings, represent the company in the role as manager and continuously inform employees as relevant
• Ensuring QA team responsibilities (project work, method transfer and validation support, calibration/OOT, archiving, EQNBs, Key Supplier management, INS SOPs, investigations, deviations, change controls, instrument validation) are assigned and managed to completion per due dates
• Inputting into the structure and responsibilities of the QA function at Recipharm, suggesting improvements to processes and procedures for Quality Assurance function in close collaboration with other groups and departments in the Company
• SME for test method validation at the site, reviewing validation protocols for adherence with ICH requirements, and appropriate test plans and acceptance criteria are applied
• Reviews and approves project requirements and deliverables for assigned projects, including protocols and test methods, Validation/Method Transfer Reports, Certificates of Analysis and Stability Reports
• Responsible to assist hosting customer audits and regulatory inspections, acting as SME for project activities audited, including managing QA responses
• Working closely with Managers and Technical Leads for fast-moving projects to ensure proper and timely communication and delivery. Following up on adherence to budget for the QA tasks.
• Ensuring the QA training program is robust and provides staff with appropriate training materials and requirements, and providing routine QA training to the sites lab staff and other staff as needed
• Contributing to SOP updates for the site, and assisting in Internal Audits on site
• Serve as subject matter expert for group activities and responsibilities both with site customer and during audits and inspections
• Other responsibilities as assigned

Other

• 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.

Qualifications

• The Manager, Quality Assurance, must have a four-year degree in Chemistry or Pharmaceutical Sciences, or related experience, and 4-8 years of experience in a pharmaceutical environment in a Quality-related field.
• Good working knowledge of computers and programs such as MS Word and Excel.
• Must possess a thorough understanding of laboratory procedures and a strong knowledge of relevant cGMP requirements
• Ability to build relations and interact effectively

Physical Requirements

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.