Quality Assurance Manager Position Available In St. Louis, Missouri

Quality Assurance Manager Equiliem Hazelwood, MO 63042

• Hybrid work The Quality Assurance Specialist supports externally manufactured products with a product portfolio that includes pharmaceutical and biopharmaceutical products.

The position is responsible for assisting in the review and writing of quality systems documentation and working with internal and external counterparts at the CMO and cross-functional team members. The position is responsible for appropriate escalation to Manager/Director level management and above.

Essential Functions Quality Support:

• Review of Stability reports, data evaluation, and record management
• Review and approval of CMO documentation for batch production
• Review of batch records, addressing discrepancies and escalating where required to management
• Review, input, and routing of quality agreements
• Quality record management; deviations, change controls, CAPAs
• Monitoring cold-chain transportation, for both qualification and routine
• Annual Product Quality Review assessment and authoring (certain sections)
• Writing quality systems documents
• Working within master Control for authoring, reviewing, routing, and approving

CMO Governance:

Regular telephone and email communication with internal partners to ensure timely manufacture and resolution of quality issues for product.

Quality/QMS Projects:

Support continuous improvement projects Education / Experience /

Skills:

• Bachelor’s Degree in scientific discipline, preferred 5+ years’ experience working within
• Quality roles with increasing responsibility.
• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
• Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically

CFR 210/211

• Sterile injectable pharmaceutical experience preferred

Competencies:

• Strong organizational skills
• Works independently
• Knowledge of Microsoft Office Suite
• MasterControl experience a plus
• Good interpersonal skills; ability to communicate well, both verbally and written
• Able to function effectively in teamwork environment
• Thorough, diligent and good attention to detail
• Collaborator with strong levels of engagement with individuals and team
• High level of delivery and work completion

Organizational Relationship/Scope:

The position reports to the

Quality Operations Manager Working Conditions:

This position works in an office type environment, although primarily remotely. Long periods of sitting are required. Use of computer and phone are required on a daily basis.

Job Types:

Full-time, Contract Pay:

$40.00

• $50.

00 per hour Expected hours: 40 per week

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Schedule:

8 hour shift Day shift Monday to

Friday Education:

Bachelor’s (Required)

Experience:

Quality management: 3 years (Required)

Medical Device:

2 years (Preferred)

CAPA:

2 years (Preferred)

Language:

English (Required) Ability to

Commute:

Hazelwood, MO 63042 (Required) Ability to

Relocate:

Hazelwood, MO 63042: Relocate before starting work (Required)

Work Location:

Hybrid remote in Hazelwood, MO 63042