Job summary
The Temporary Quality Specialist, Analytical Sciences is responsible for authoring and revising Standard Operating Procedures (SOPs) and Work Instructions (WIs), in addition to but not limited to reviewing, equipment manuals, protocols, installation guides, and technical specifications for the required cGMP processes. This position requires knowledge and understanding of cGMP quality documentation requirements and regulatory compliance. The Temporary Quality Specialist, Analytical Sciences,will work closely with cross-functional teams, including Analytical Sciences and Quality Assurance to ensure accurate and timely documentation is authored.
This position also requires initiative, the ability to work well with others, the willingness to take on new responsibilities and the ability to communicate and follow up on deadlines and requirements.Essential job functions and duties
- Author and/or revise cGMP technical documentation required to meet laboratory standards, including but not limited to SOPs, WIs, design specifications, study protocols, study reports, verification and validation reports to support cGMP implementation.
- Collaborate with cross-functional teams to gather information and ensure documentation is accurate, complete and consistent.
- Knowledge of Document Control principles.
- Follows Good Documentation Practice (GDP) for all cGMP documentation authored and/or revised.
- Performs other related tasks as assigned.
Minimum requirements
- Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
- 3 -5 years’ experience in medical device or pharmaceutical/ biotech industry, with working knowledge of FDA and ISO regulations.
- 3-5 years of experience with cGMP and GDP
- Authoring cGMP laboratory and/or quality SOPs
- Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner.
- Ability to read, analyze, and interpret technical procedures and regulations. Ability to author reports and procedure manuals. Ability to effectively present information and respond to questions.
- Must be able to work under minimum supervision and in a team environment.
The hourly range for this role is $37.25 to $46.51. Individual pay decisions ultimately depend on various factors including, but not limited to, relevant experience, knowledge, skills, education, geography, internal equity and alignment with external market data.
Disclaimer
INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.A current US work authorization is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
