Lead Document Control Specialist-10Am To 6:30Pm

SUMMARY

The Lead Document Control Specialist is responsible for managing Wells Pharma of Houston’s documents while ensuring their accuracy, quality, and integrity. The candidate must adhere to the record retention policies, safeguard information, and retrieve data more effectively.

The Lead Document Control Specialist responsible for ensure all controlled documents are current, accurate, and submitted to DCU for retention.

This position will work under the direction of the Quality Management

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for the scan, imaging, organizing, and maintaining documents

• Adhere to the company’s life cycle procedures for document retention including archiving inactive records.

• Ability to receive and process Request for Information from employees or clients while maintaining the requests via tracking logs.

• Ability to work independently and is self-directed.

• Must be computer savvy and well-versed in Microsoft Software, BarTender, and other document management systems.

• Familiar with GxP requirement in a 503B facility

• Create, review, revision, or approval of summary reports, SOPs, and policies or procedures.

• Work in conjunction with the QA management in approving all company documents requiring a QA signatory: Examples: Cleaning records, Operations, etc.

• Issue Deviation, CAPA, Out of Specification, or incident unique tracking numbers when non-conformances arise.

• Maintain & update personnel training folders to make sure that they are current.

• Maintain departmental SOP binders to ensure the most current revision is present

• Issue logbooks as requested by departments.

• Printing of Batch Records and assigning lot numbers for the batch compounded

• Label Printing, verification, and reconciliation

• Complete non-conformance investigation and document on the appropriate form

• Provide oversight and training for DCU associates and other QA associates performing Document Control tasks.

• Act as a liaison during internal and external audits to ensure documents are retreived in a timely manner.

• Perform additional duties as assigned by Quality management

KNOWLEDGE, SKILLS, & ABILITIES

• Knowledge of cGMP regulations as it pertains to 21 CFR 210, 211 and 503B regulated environments.

• Strong verbal, written communication skills and computer skills are required.

• Must be goal-oriented, quality-conscientious, and customer-focused.

• Knowledge of laboratory science and aseptic techniques principles.

• Effective oral and written communication skills.

• Ability to read, understand, and follow work instruction to ensure that documents are submitted, revised, reviewed and updated/retrieved in each department.

• Very logbooks for completeness and GDP errors throughout the facility.

• Ability to work independently and cooperatively on a team.

CORE VALUES

• The Lead Document Control Specialist is expected to operate within the framework of Wells Pharma’s Core Values.

• Consistently operate with the highest standards of ethics and compliance.

• Take ownership of your actions, success and setbacks.

• Exercise respect and honesty.

• Readily adapt to the culture that is patient focused and dedicated to making a difference.

COMPANY SUCCESS

• Go the extra mile to make things happen and be committed in all aspects.

• Embrace change with enthusiasm, giving positive criticism, respectfully.

EDUCATION & EXPERIENCE

• Must have a Bachelor’s degree or equivalent of 5 - 7 years of experience with Document Control or in a cGMP Pharmaceutical Environment.

• Able to work independently for an extended period while sitting or standing.

• Ability to read, understand, and follow detailed written procedures (StandardOperating Procedures).

• Must be experienced using a scanner and computer

• Must be able to make routine decisions while following established guidelines and/orprocedures.

• Must have good written and oral communication skills.

• Must be able to lift and carry up to 25 lbs.

Job Type: Full-time

Pay: $60,000.00 - $66,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Do youhave knowledge of cGMP regulations as it pertains to 21 CFR 210, 211 and 503B regulated environments? Required
• Do you have knowledge of laboratory science and aseptic techniques principles? Required
• Do you h have a Bachelor’s degree or equivalent of 5 - 7 years of experience with Document Control or in a cGMP Pharmaceutical Environment? Reuqired

Work Location: In person