Technical Writer II, III - Pharmaceuticals

Technical Writer II, III - Pharmaceuticals

UPM Pharmaceuticals is an independent, highly experienced and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.

Summary:

Create, maintain, and revise, forms, standard operating procedures, batch records, and material specifications to improve efficiencies while enhancing company GMP compliance. Author and collaborate with authors/initiators of Manufacturing/Packaging/Laboratory Notice of Events (NOEs) and Investigations and subsequently identify appropriate Corrective and Preventative Actions (CAPAs).

Essential Duties and Responsibilities:

1. Lead and conduct cross functional investigations, deviations, and product complaints related to the site. Determine and implement appropriate corrective and preventative actions based on the outcome of investigations.

2. Analyze existing procedures for alignment with department methods and production records relative to company policies, governmental regulations and license requirements. Specifically, documents related to batch records, standard operating procedures, and forms. Identify opportunities for improvement and implement.

3. Lead in authoring/collaborating with authors of the procedures that reflect the most effective systems within company policies and government regulations to improve employee understanding and enhance usability without error.

4. Work with cross-functional teams to gather information as requested for inclusion in their procedure, specification, or batch record.

5. Collaborate with the Training group to identify gaps/opportunities for improvement that are identified regarding personnel training that result from investigation findings.

6. Perform other duties as required.

Education/Experience:

Technical Writer I: Bachelor’s degree in a science/engineering related field and at least five years of pharmaceutical experience in a GMP environment, or equivalent combination of education and experience.

Technical Writer II: Bachelor’s degree in a science/engineering related field and at least fifteen years of pharmaceutical experience in a GMP environment, or equivalent combination of education and experience.

What we offer you:

• Leading pay for all positions
• All employees enjoy generous paid time off including 11 paid holidays
• 17 paid PTO days
• Health Insurance, Dental Insurance, Vision Insurance – effective day one with

low-cost premiums available for single or family coverage

• Company paid employee assistance program
• 4% 401K company match
• Company paid life insurance, long term, and short-term disability
• Many discounts on products and services made available to employees
• Employee Referral Awards
• Onsite fitness center
• Relocation assistance

Qualified candidates must be authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment Visa Status (e.g., H-1B or TN Status) for this employment position.

Job Type: Full-time

Pay: $1.00 - $2.00 per hour

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Ability to Relocate:

• Bristol, TN 37620: Relocate before starting work (Required)

Work Location: In person