Senior QA Associate

Senior QA Associate
Req#: 51320031




 

At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.



Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



PRIMARY OBJECTIVE:

Serve as the primary resource for quality assurance functions for product development of aptamers and analytical methods related to DNA analytical techniques and characterization methodology in pharmaceutical development. Performs quality assurance operations for Elan's development products and its contract manufacturers. Assists in the timely and cGMP compliant release of products. Assures the product produced is maintained in a state of cGMP compliance. Audits testing and manufacturing records, assists in cGMP product- and operations-related investigations and performs QA activities coordinated with manufacturing operations. May be involved, due to expertise in this area, in setting up methods, setting standards and criteria regarding aptamers and DNA products. May supervise subordinate QA associates upon assignment. Provides quality leadership in completing investigations and resolving deviations or special problems.

DUTIES/RESPONSIBILITIES:

- Review Quality Control and Analytical Development data relating to aptamer and DNA based therapeutic products to assure cGMP compliance.
- Upon assignment, serves in liaison position with partners and contracted service organizations involved in the clinical supply chain regarding aptamer and associated products.
- Provides training and guidance in terms of cGMP compliance in operations and quality control laboratories.
- Provides information, training, and takes initiatives towards new regulatory guidance affecting the plant operations or product standards.
- Reviews documentation (e.g. QC data, batch production records) generated at the Production Facility assuring conformity to approved procedures and the cGMPs.
- Maintains, updates, and audits several databases to track controlled documents (e.g. serialized datasheets, training records, APNs, validation packages, etc.)
- Provides QA support during quality internal audits and regulatory inspections.
- Provides basic cGMP training.
- Supports all QA functions to all areas of Pharmaceutical Development.
- Assists in performing supplier, contract lab and internal audits of internal operations.
- Witnesses critical manufacturing processes.
- Assists in review of document changes and change control relating to development products.

TRAVEL:

15% Domestic Travel required.

MINIMUM EDUCATION/EXPERIENCE:

B.S./B.A. with a degree in chemistry, biochemistry, microbiology or other related science. Plus be experienced in DNA and aptamer based technology and analytical techniques for use in product development.

Experience with quality assurance responsibilities of pharmaceutical operations and knowledge of cGMPs. 3- 5 years experience in a GMP regulated industry Knowledge and experience of analytical methodology required to develop aptamers and DNA based products.

PREFERRED EDUCATION/EXPERIENCE:

BS or MS in related science and 3 to 5 years in industry post graduate preferred but not required.

SPECIAL TRAINING:

Knowledge and or experience with DNA and aptamer product development and analytical methodology.
Must be able to coordinate the flow of documents between QA and other departments. Skilled in word processing and database computer applications. Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.

SKILLS/ABILITIES:

Good understanding of GMP and ICH regulations, and DNA and aptamer based analytical methodologies. Must have good interpersonal skills with ability to interface constructively with other departments and contractors.

 

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