Work Location: Marlborough, MA
Job Title: QA/RA Compliance Lead
Duration: 12 Months
Monday - Friday 8 am- 5 pm
• Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety.
• assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities
• supporting risk management process throughout the product life cycle and providing senior mgt with key data from RA to help drive decisions.
• Supporting, development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies
• Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
• communicates and implements a strategy to ensure compliance
• responsible for review of batch records in support of disposition of bulk drug substance
• responsible for review of equipment validation protocols and report
• general compliance quality systems management support for the following areas:
• Raw material and solution release
• Review of raw material specifications and solution docs
• Release of single use disposable product to include label reconciliation
• review of temp. charts and docs or temp related excursions
• review and update label issuance and reconciliation process
General QA documentation support to include the following:
• Issuance of batch records and issuance and tracking of log books, lab notebooks and SOP binders
• Scanning and filing of excursion docs and client related batch docs to support batch release
• Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc.
• BA degree or a min. of 5yrs work exp.
• 3 years exp working in a regulated industry
• Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211
• Demonstrated exp. and proficiency with MS Office, word processing, spreadsheet(Excel), presentation and database applications.
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.