Documentation Specialist

Lancesoft

Round Rock, IL

Apply

JOB DETAILS

SALARY

$30

LOCATION

Round Rock, IL

POSTED

30+ days ago

The hours of operations will be 7am-3: 30pm.

This individual will be working in the Penicillin Building so they cannot be allergic to Penicillin
Summary:

This position reports to the Manufacturing functional areas. This position provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure the compliance with cGMP, Company Policies and local SOPs.

Essential Duties and Responsibilities:

Supporting manufacturing’s batch documentation review.
Responsible for ensuring manufacturing’s batch records meet specifications and submitted to Quality per release schedule
Assure batch documentation complies with GDP standards.
Determine acceptability by using specifications and standard operating procedures.
Ensure presence of all required documentation prior to the submission of batch folder to Quality.
Maintain files such that documents are readily available and easily retrievable.
Initiate and close GME work orders.
Author Non-Conformance Records (NCRs) and Exceptions Investigations
Author TCU documentation changes including revisions, periodic reviews and GAP assessments
Use Maximo system to print department preventative maintenance work orders;assign and bring to completion, as necessary.
Use SYSTECH to review and approve counts for batches.
Initiate batch folders by performing necessary data entry.
Support GME cycle counting as needed
Other administrative duties as assigned.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Strong computer skills in MS Office Suite.
Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
Strong attention to detail.
Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks.
Ability to communicate efficiently verbally and in writing with all levels of the organization.
Identify areas for continuous improvement.
Individual must be willing to adjust work hours and work overtime based on business needs.
Must be able to lift 30 pounds.
Must not be allergic to Penicillin or Cephalosporin drugs.

Education and/or Experience:

Include the education and experience that is necessary to perform the job satisfactorily.
Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.

About the Company

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/